FDA Product Code
FDA Product Code JIT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1150
510(k) Clearances — 245 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017-05-16 | Abbreviated | PDF ↗ |
| K170938 | CalSet IGF-1 | Roche Diagnostics | 2017-04-26 | Traditional | PDF ↗ |
| K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | 2017-02-15 | Traditional | PDF ↗ |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 | Abbreviated | PDF ↗ |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 | Abbreviated | PDF ↗ |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-12 | Abbreviated | PDF ↗ |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017-01-12 | Abbreviated | PDF ↗ |
| K163078 | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 | Abbreviated | PDF ↗ |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016-12-01 | Abbreviated | PDF ↗ |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics | 2016-11-17 | Special | PDF ↗ |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | 2016-02-17 | Traditional | PDF ↗ |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | 2015-12-18 | Traditional | PDF ↗ |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | 2015-10-02 | Traditional | PDF ↗ |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | 2015-07-10 | Traditional | PDF ↗ |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Beckman Coulter, Inc. | 2015-02-26 | Special | PDF ↗ |
| K143342 | Elecsys T-Uptake Calset | Roche Diagnostics | 2014-12-19 | Traditional | PDF ↗ |
| K143144 | ST AIA-PACK PROG II Calibrator Set | Tosoh Bioscience, Inc. | 2014-12-03 | Traditional | PDF ↗ |
| K142181 | RANDOX ALDOLASE CALIBRATION SERUM | Randox Laboratories Limited | 2014-09-18 | Traditional | PDF ↗ |
| K142021 | Elecsys Estradiol III CalSet | Roche Diagnostics | 2014-08-12 | Traditional | PDF ↗ |
| K133751 | DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS | Diamond Diagnostics, Inc. | 2014-08-08 | Traditional | PDF ↗ |
| K141728 | ACE CALIBRATOR | SENTINEL CH. SpA | 2014-07-28 | Abbreviated | PDF ↗ |
| K141374 | BICARBONATE CALIBRATOR | Beckman Coulter Ireland, Inc. | 2014-06-30 | Abbreviated | PDF ↗ |
| K140112 | CA 125 II CALSET II | Roche Diagnostics | 2014-06-06 | Traditional | PDF ↗ |
| K140648 | ST AIA-PACK C-PEPTIDE II CALIBRATOR SET | Tosoh Bioscience, Inc. | 2014-04-10 | Abbreviated | PDF ↗ |
| K130603 | PATHFAST CTNL CALIBRATORS | Mitsubishi Chemical Medience Corporation | 2014-03-27 | Special | PDF ↗ |
| K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS | Biokit, S.A. | 2013-12-19 | Abbreviated | PDF ↗ |
| K130628 | PATHFAST CK-MB-II CALIBRATORS | Mitsubishi Chemical Medience Corporation | 2013-10-04 | Special | PDF ↗ |
| K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET | Diazyme Laboratories | 2013-06-26 | Special | PDF ↗ |
| K130698 | DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) | Siemens Healthcare Diagnostics | 2013-04-05 | Abbreviated | PDF ↗ |
| K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL | Elitechgroup | 2013-02-15 | Abbreviated | PDF ↗ |
| K121027 | DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH | Diamond Diagnostics, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K120591 | DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 | Diamond Diagnostics, Inc. | 2012-04-17 | Traditional | PDF ↗ |
| K113373 | DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL | Siemens Healthcare Diagnostics, Inc. | 2011-12-30 | Abbreviated | PDF ↗ |
| K111952 | ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 | Beckman Coulter, Inc. | 2011-08-19 | Abbreviated | PDF ↗ |
| K111762 | ST AIA-PACK DHEA-S CALIBRATOR SET | Tosoh Bioscience, Inc. | 2011-08-05 | Abbreviated | PDF ↗ |
| K111023 | ABBOTT ARCHITECT LH CALIBRATORS | Abbott Laboratories | 2011-06-10 | Traditional | PDF ↗ |
| K103548 | ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 | Siemens Healthcare Diagnostics, Inc. | 2011-06-02 | Abbreviated | PDF ↗ |
| K110169 | DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H | Siemens Healthcare Diagnostics | 2011-04-07 | Traditional | PDF ↗ |
| K103836 | ENZYME II CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2011-02-16 | Traditional | PDF ↗ |
| K103221 | ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 | Roche Diagnostics | 2010-12-23 | Traditional | PDF ↗ |
| K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL | Siemens Corp. | 2010-12-17 | Traditional | PDF ↗ |
| K102638 | DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS | Diazyme Laboratories | 2010-11-30 | Abbreviated | PDF ↗ |
| K092937 | STA-HYBRID HEP CALIBRATOR | Diagnostica Stago, Inc. | 2010-08-02 | Traditional | PDF ↗ |
| K093357 | DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D | Diamond Diagnostics, Inc. | 2010-06-24 | Traditional | PDF ↗ |
| K100293 | ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 | Siemens Heatlhcare Diagnostics, Inc. | 2010-03-19 | Abbreviated | PDF ↗ |
| K092570 | ABX PENTRA TPU CAL, MODEL A11A01898 | HORIBA ABX SAS | 2009-10-16 | Abbreviated | PDF ↗ |
| K083462 | DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 | Siemens Healthcare Diagnostics | 2009-02-27 | Traditional | PDF ↗ |
| K082680 | LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 | Siemens Healthcare Diagnostics | 2008-10-10 | Abbreviated | PDF ↗ |
| K081789 | DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2008-09-10 | Traditional | PDF ↗ |
| K082141 | ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 | Biokit, S.A. | 2008-09-03 | Abbreviated | PDF ↗ |
| K081319 | DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 | Siemens Healthcare Diagnostics, Inc. | 2008-08-04 | Abbreviated | PDF ↗ |
| K081683 | LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 | Siemens Healthcare Diagnostics | 2008-07-07 | Traditional | PDF ↗ |
| K080166 | ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 | Beckman Coulter, Inc. | 2008-03-19 | Special | PDF ↗ |
| K072717 | DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 | Dade Behring, Inc. | 2007-12-12 | Traditional | PDF ↗ |
| K071039 | MISSION OLYMPUS AU ISE CALIBRATORS | Diamond Diagnostics, Inc. | 2007-08-08 | Traditional | PDF ↗ |
| K070552 | DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) | Dade Behring, Inc. | 2007-04-30 | Traditional | PDF ↗ |
| K062521 | OXALATE URINE CONTROLS (NORMAL AND ELEVATED) | Thermo-Electron Corp. | 2007-03-16 | Traditional | PDF ↗ |
| K070144 | INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2007-02-01 | Traditional | PDF ↗ |
| K060854 | ABX PENTRA 400: LIPOPROTEINS | Horiba Abx | 2006-08-24 | Traditional | PDF ↗ |
| K062152 | CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 | Dade Behring, Inc. | 2006-08-16 | Traditional | PDF ↗ |
| K061885 | DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 | Dade Behring, Inc. | 2006-08-14 | Traditional | PDF ↗ |
| K061818 | DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) | Dade Behring, Inc. | 2006-07-18 | Traditional | PDF ↗ |
| K061751 | DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 | Dade Behring, Inc. | 2006-07-13 | Traditional | PDF ↗ |
| K061702 | DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) | Dade Behring, Inc. | 2006-07-10 | Traditional | PDF ↗ |
| K061139 | BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS | Bayer Healthcare, LLC | 2006-07-06 | Abbreviated | PDF ↗ |
| K061282 | ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 | Beckman Coulter, Inc. | 2006-06-02 | Special | PDF ↗ |
| K060140 | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 | Diagnostic Chemicals , Ltd. | 2006-04-24 | Traditional | PDF ↗ |
| K060754 | ELECSYS TSH CALSET W/MODELS 04738551 | Roche Diagnostics Corp. | 2006-04-18 | Special | PDF ↗ |
| K060359 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 | Denka Seiken Co., Ltd. | 2006-04-14 | Abbreviated | PDF ↗ |
| K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED | Cliniqa Corporation | 2006-03-21 | Traditional | PDF ↗ |
| K053291 | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 | Reference Diagnostics, Inc. | 2006-03-13 | Abbreviated | PDF ↗ |
| K060371 | THE EMIT 2000 TACROLIMUS CALIBRATORS | Dade Behring, Inc. | 2006-03-09 | Traditional | PDF ↗ |
| K053576 | DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR | Dade Behring, Inc. | 2006-02-07 | Traditional | PDF ↗ |
| K053330 | ARCHITECT B12 CALIBRATORS | Abbott Laboratories | 2005-12-16 | Special | PDF ↗ |
| K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET | Reference Diagnostics, Inc. | 2005-11-09 | Abbreviated | PDF ↗ |
| K052982 | ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET | Roche Diagnostics | 2005-10-28 | Special | PDF ↗ |
| K052193 | ISE COMPENSATOR | Roche Diagnostics | 2005-10-03 | Traditional | PDF ↗ |
| K052002 | IRON STANDARD | Roche Diagnostics Corp. | 2005-08-22 | Traditional | PDF ↗ |
| K051012 | PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. | Salimetrics, LLC | 2005-07-19 | Traditional | PDF ↗ |
| K050231 | ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET | Roche Diagnostics Corp. | 2005-07-06 | Traditional | PDF ↗ |
| K043378 | DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT | Drew Scientific , Ltd. | 2004-12-29 | Abbreviated | PDF ↗ |
| K042838 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II | Ortho-Clinical Diagnostics, Inc. | 2004-12-09 | Traditional | PDF ↗ |
| K042406 | OLYMPUS LACTATE, OSR6193 | Olympus America, Inc. | 2004-12-03 | Traditional | PDF ↗ |
| K043095 | ROCHE DIAGNOSTICS ELECSYS AFP CALSET II | Roche Diagnostics Corp. | 2004-11-23 | Special | PDF ↗ |
| K042521 | VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 | Traditional | PDF ↗ |
| K042307 | ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) | Seradyn, Inc. | 2004-11-03 | Abbreviated | PDF ↗ |
| K042651 | FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2004-10-05 | Traditional | PDF ↗ |
| K042490 | ELECSYS FOLATE II CALSET II | Roche Diagnostics Corp. | 2004-09-30 | Special | PDF ↗ |
| K033860 | AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR | Wako Chemicals USA, Inc. | 2004-04-23 | Traditional | PDF ↗ |
| K040692 | OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 | Olympus America, Inc. | 2004-04-08 | Special | PDF ↗ |
| K040226 | WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET | Wako Chemicals USA, Inc. | 2004-03-25 | Traditional | PDF ↗ |
| K040471 | OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 | Olympus America, Inc. | 2004-03-10 | Special | PDF ↗ |
| K033060 | CALIBRATING MATERIAL, CALIBRATING STANDARDS | Diamond Diagnostics, Inc. | 2004-03-04 | Traditional | PDF ↗ |
| K033786 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA | Ibl GmbH | 2004-02-27 | Traditional | PDF ↗ |
| K033643 | CO2 CALIBRATOR/DILUENT | Bayer Healthcare, Diagnostics Division | 2004-01-08 | Abbreviated | PDF ↗ |
| K032458 | ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT | Abbott Laboratories | 2003-10-06 | Abbreviated | PDF ↗ |
| K032285 | OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 | Olympus America, Inc. | 2003-08-21 | Abbreviated | PDF ↗ |
| K031924 | VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 | Ortho-Clinical Diagnostics | 2003-08-07 | Traditional | PDF ↗ |
| K031159 | CALIBRATING MATERIAL, CALIBRATING STANDARDS | Diamond Diagnostics, Inc. | 2003-06-25 | Traditional | PDF ↗ |
| K031299 | ELECSYS LH CALSET II | Roche Diagnostics Corp. | 2003-05-12 | Special | PDF ↗ |
Product code JIT · Class II · Clinical Chemistry. Data: openFDA.