FDA Product Code
FDA Product Code JIS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1150
510(k) Clearances — 130 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122126 | DIRECT LDL/HDL CHOLESTEROL CALIBRATOR | Randox Laboratories Limited | 2012-08-14 | Traditional | PDF ↗ |
| K061251 | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | Dade Behring, Inc. | 2006-05-31 | Traditional | PDF ↗ |
| K060266 | DIMENSION IRON CALIBRATOR | Dade Behring, Inc. | 2006-03-09 | Traditional | PDF ↗ |
| K053104 | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR | Dade Behring, Inc. | 2005-12-23 | Traditional | PDF ↗ |
| K032697 | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | Dade Behring, Inc. | 2003-11-07 | Traditional | PDF ↗ |
| K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 2003-10-21 | Abbreviated | PDF ↗ |
| K032296 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 2003-08-13 | Special | PDF ↗ |
| K030964 | CALIBRATION PLASMA LMW HEPARIN | Instrumentation Laboratory CO | 2003-06-06 | Traditional | PDF ↗ |
| K030546 | CRP (II) CALIBRATORS | Denka Seiken Co., Ltd. | 2003-06-02 | Traditional | PDF ↗ |
| K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET | Wako Chemicals USA, Inc. | 2003-04-11 | Traditional | PDF ↗ |
| K022682 | RANDOX C-REACTIVE PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2002-11-05 | Traditional | PDF ↗ |
| K022901 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics | 2002-09-27 | Special | PDF ↗ |
| K013126 | N LP(A) STANDARD SY | Dade Behring, Inc. | 2001-11-09 | Traditional | PDF ↗ |
| K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | Thermo Dma, Inc. | 2001-10-16 | Abbreviated | PDF ↗ |
| K011568 | RANDOX LIPOPROTEIN | Randox Laboratories, Ltd. | 2001-09-28 | Traditional | PDF ↗ |
| K010696 | BECKMAN COULTER DNASE B CALIBRATOR | Beckman Coulter, Inc. | 2001-05-10 | Traditional | PDF ↗ |
| K003941 | ELECSYS HCG STAT CLASET II | Roche Diagnostics Corp. | 2001-01-25 | Traditional | PDF ↗ |
| K003969 | ELECSYS CA 125 II CALSET | Roche Diagnostics Corp. | 2001-01-12 | Special | PDF ↗ |
| K002760 | ELECSYS DHEA-S CALSET | Roche Diagnostics Corp. | 2000-10-05 | Traditional | PDF ↗ |
| K002353 | ELECSYS CA 15-3 CALCHECK | Roche Diagnostics Corp. | 2000-08-10 | Traditional | PDF ↗ |
| K001906 | ELECSYS INSULIN CALSET | Roche Diagnostics Corp. | 2000-07-13 | Traditional | PDF ↗ |
| K001005 | WAKO HDL-C/LDL-C CALIBRATOR | Wako Chemicals USA, Inc. | 2000-06-01 | Special | PDF ↗ |
| K001004 | WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR | Wako Chemicals USA, Inc. | 2000-06-01 | Traditional | PDF ↗ |
| K001002 | WAKO LIPASE CALIBRATOR | Wako Chemicals USA, Inc. | 2000-05-24 | Traditional | PDF ↗ |
| K000331 | SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-10 | Traditional | PDF ↗ |
| K994169 | SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-03 | Traditional | PDF ↗ |
| K994168 | SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-02-03 | Traditional | PDF ↗ |
| K994114 | DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR | Dade Behring, Inc. | 2000-01-20 | Traditional | PDF ↗ |
| K994325 | SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR | Beckman Coulter, Inc. | 2000-01-12 | Traditional | PDF ↗ |
| K994145 | VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 1999-12-22 | Special | PDF ↗ |
| K993219 | WAKO BILIRUBIN CALIBRATOR | Wako Chemicals USA, Inc. | 1999-11-09 | Traditional | PDF ↗ |
| K983640 | SYNCHRON SYSTEMS LIPID CALIBRATOR | Beckman Coulter, Inc. | 1998-12-21 | Traditional | PDF ↗ |
| K970933 | AUTO HDL CHOLESTEROL CALIBRATOR | Pointe Scientific, Inc., | 1997-05-23 | Traditional | PDF ↗ |
| K963847 | WAKO DIRECT HDL-C | Wako Chemicals USA, Inc. | 1996-12-24 | Traditional | PDF ↗ |
| K964475 | CLINICAL BLOOD GAS MIXTURES | Oxarc, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K954546 | BLOOD GAS MIXTURE | Liquid Technology Corp. | 1995-12-28 | Traditional | PDF ↗ |
| K951964 | SYNCHRON ENZYME VALIDATOR SET | Beckman Instruments, Inc. | 1995-06-29 | Traditional | PDF ↗ |
| K951585 | T-UPTAKE CALIBRATORS | Diagnostic Reagents, Inc. | 1995-06-15 | Traditional | PDF ↗ |
| K951629 | IMX ESTRADIOL | Abbott Laboratories | 1995-05-17 | Traditional | PDF ↗ |
| K944701 | CALIBRATORS | Diagnostic Reagents, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K940008 | GLYCATED PROTEIN CALIBRATORS | Primus Corp. | 1994-05-09 | Traditional | PDF ↗ |
| K936201 | URINARY ALBUMIN CALIBRATOR | Dupont Medical Products | 1994-03-11 | Traditional | PDF ↗ |
| K931834 | KING SODIUM/POTASSIUM STANDARD MODIFIED | King Diagnostics, Inc. | 1993-08-25 | Traditional | PDF ↗ |
| K932555 | DC-LINEATE CAT. NO. SE-091 | Diagnostic Chemicals, Ltd. (Usa) | 1993-08-19 | Traditional | PDF ↗ |
| K930501 | DU PONT ACA NEV/EEV VERIFIER | Dupont Medical Products | 1993-08-09 | Traditional | PDF ↗ |
| K922646 | REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM | Behring Diagnostics, Inc. | 1993-06-25 | Traditional | PDF ↗ |
| K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR | Analytical Control Systems, Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K925877 | DC-UIBC-CAL | Diagnostic Chemicals, Ltd. (Usa) | 1993-03-18 | Traditional | PDF ↗ |
| K924904 | HDL-CHOLESTEROL STANDARD, MODIFICATION | Verichem Laboratories, Inc. | 1993-01-13 | Traditional | PDF ↗ |
| K922699 | DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR | E.I. Dupont DE Nemours & Co., Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K922698 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K922696 | DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO | E.I. Dupont DE Nemours & Co., Inc. | 1992-08-12 | Traditional | PDF ↗ |
| K921855 | BIOTROL BICARBONATE STANDARDS | Biotrol, USA, Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K921903 | THYROXINE CALIBRATOR KIT | Tudor Laboratories, Inc. | 1992-05-26 | Traditional | PDF ↗ |
| K920809 | KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD | King Diagnostics, Inc. | 1992-04-17 | Traditional | PDF ↗ |
| K910721 | BIOTROL PROTEIN MULTILEVEL STANDARDS | Biotrol, USA, Inc. | 1991-05-06 | Traditional | PDF ↗ |
| K905820 | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI | E.I. Dupont DE Nemours & Co., Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K905477 | OLYMPUS URINE PH CALIBRATORS LEVELS I AND II | Em Diagnostic Systems, Inc. | 1991-02-13 | Traditional | PDF ↗ |
| K901113 | MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD | Verichem Laboratories, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K895778 | QUANTIMETRIX BILIRUBIN CALIBRATORS | Quantimetrix Medical Industries | 1989-11-14 | Traditional | PDF ↗ |
| K895585 | HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) | Hichem Diagnostics | 1989-11-13 | Traditional | PDF ↗ |
| K884168 | ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. | The DU Pont Co. | 1988-11-29 | Traditional | PDF ↗ |
| K882726 | RAICHEM(TM) BILIRUBIN STANDARD | Reagents Applications, Inc. | 1988-08-29 | Traditional | PDF ↗ |
| K881693 | TERUMO SENSIBEAD EIA PROGESTERONE KIT | Terumo Medical Corp. | 1988-06-07 | Traditional | PDF ↗ |
| K872051 | CALCIUM CALIBRATOR | Wako Chemicals USA, Inc. | 1987-09-18 | Traditional | PDF ↗ |
| K871185 | LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 | In Vitro Diagnostics, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K871188 | LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086 | In Vitro Diagnostics, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K871187 | LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 | In Vitro Diagnostics, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K871186 | CESIUM DILUENT 1.5 MMOL CS/L #60087 | In Vitro Diagnostics, Inc. | 1987-05-28 | Traditional | PDF ↗ |
| K870379 | ISE COMPENSATION SERA | Boehringer Mannheim Corp. | 1987-02-26 | Traditional | PDF ↗ |
| K862453 | EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 | Em Diagnostic Systems, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862704 | EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 | Em Diagnostic Systems, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | Traditional | PDF ↗ |
| K861769 | GENTAMICIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | Traditional | PDF ↗ |
| K861891 | TOBRAMYCIN (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | Traditional | PDF ↗ |
| K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT | Windsor Laboratories, Inc. | 1986-06-25 | Traditional | PDF ↗ |
| K855040 | SERALYZER TOTAL BILIRUBIN CALIBRATORS | Miles Laboratories, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K852068 | TOTAL BILIRUBIN STANDARDS | Data Medical Associates, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K844581 | 80 MG/DL GLUCOSE CONTROL | Boehringer Mannheim Corp. | 1984-12-12 | Traditional | PDF ↗ |
| K844235 | CHLORIDE STANDARD | Shaban Mfg. Co. | 1984-11-20 | Traditional | PDF ↗ |
| K843110 | ROCHE STANDARDS FOR CHOLESTEROL | Roche Diagnostic Systems, Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K842450 | HICHEM ION 2/4 URINE RANGE CALIBRATOR | Hi Chem, Inc. | 1984-08-16 | Traditional | PDF ↗ |
| K842449 | HICHEM ION 2/4 SERUM RANGE CALIBRATOR | Hi Chem, Inc. | 1984-08-16 | Traditional | PDF ↗ |
| K841955 | DUPONT ACA MAGNESIUM CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K840217 | CHOLESTEROL AQUEOUS STANDARD | Preventive Diagnostics Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K840220 | HDL CHOLESTEROL AQUEOUS STANDARDS | Preventive Diagnostics Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K840299 | PH ELECTRODE CALIBRATING BUFFERS-BLOOD | Bionostics, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K832251 | PRECISET CHOLESTEROL HIGH PERFORM | Boehringer Mannheim Corp. | 1983-08-24 | Traditional | PDF ↗ |
| K830283 | LITHIUM DILUENT | Shaban Mfg. Co. | 1983-02-28 | Traditional | PDF ↗ |
| K830137 | CALIBRATOR A | Hi Chem, Inc. | 1983-02-07 | Traditional | PDF ↗ |
| K823147 | URIC ACID STANDARD, 8MG/DL #65078 | Harleco Diagnostics | 1982-11-22 | Traditional | PDF ↗ |
| K822473 | CALCIUM STANDARD, ITEM #65075 | Emd Chemicals, Inc. | 1982-09-17 | Traditional | PDF ↗ |
| K822477 | CREATININE STANDARD #65072 | Emd Chemicals, Inc. | 1982-09-17 | Traditional | PDF ↗ |
| K822474 | CHOLESTEROL STANDARD #65077 | Emd Chemicals, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822476 | PHOSPHOROUS STANDARD #65073 | Emd Chemicals, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822232 | ACA URINARY PROTEIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K822332 | C-REACTIVE PROTEIN TEST KIT | Sclavo, Inc. | 1982-08-16 | Traditional | PDF ↗ |
| K821934 | BIO-CAL OPERATION CHECK KIT | Bio-Analytics Laboratories, Inc. | 1982-07-20 | Traditional | PDF ↗ |
| K821937 | SYVA ADVANCE STANDARDIZATION KIT #2 | Syva Co. | 1982-07-16 | Traditional | PDF ↗ |
| K821938 | SYVA ADVANCE STANDARDIZATION KIT #3 | Syva Co. | 1982-07-16 | Traditional | PDF ↗ |
Product code JIS · Class II · Clinical Chemistry. Data: openFDA.