FDA Product Code
FDA Product Code JIX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1150
510(k) Clearances — 302 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K011035 | DIMENSION DRUG CALIBRATOR, MODEL DC22B | Dade Behring, Inc. | 2001-06-14 | Traditional | PDF ↗ |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | Sigma Diagnostics, Inc. | 2001-03-30 | Traditional | PDF ↗ |
| K010030 | LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR | Synergent Biochem Inc.-Clinical Controls Div. | 2001-02-14 | Traditional | PDF ↗ |
| K002804 | N PROTEIN STANDARD SL | Dade Behring, Inc. | 2000-10-05 | Traditional | PDF ↗ |
| K001484 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 | Alko Diagnostic Corp. | 2000-06-19 | Traditional | PDF ↗ |
| K000576 | ELECSYS CORTISOL CALCHECK | Roche Diagnostics Corp. | 2000-03-21 | Traditional | PDF ↗ |
| K993853 | K-ASSAY MULTI-ANALYTE CALIBRATOR | Kamiya Biomedical Co. | 1999-12-27 | Traditional | PDF ↗ |
| K993606 | K-ASSAY APO A1/B CALIBRATOR SET | Kamiya Biomedical Co. | 1999-11-26 | Traditional | PDF ↗ |
| K992845 | HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT | Elan Holdings, Inc. | 1999-10-18 | Traditional | PDF ↗ |
| K993098 | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 | Data Medical Associates, Inc. | 1999-10-08 | Traditional | PDF ↗ |
| K992086 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 | Olympus America, Inc. | 1999-08-19 | Traditional | PDF ↗ |
| K991166 | K-ASSAY MICROALBUMIN CALIBRATOR SET | Kamiya Biomedical Co. | 1999-06-10 | Traditional | PDF ↗ |
| K991181 | MODIFICATION OF N PROTEIN STANDARD SL | Dade Behring, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K990460 | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) | Roche Diagnostics Corp. | 1999-03-22 | Traditional | PDF ↗ |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | Boehringer Mannheim Corp. | 1999-01-20 | Traditional | PDF ↗ |
| K984014 | SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 | Beckman Coulter, Inc. | 1998-12-23 | Traditional | PDF ↗ |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Boehringer Mannheim Corp. | 1998-11-25 | Traditional | PDF ↗ |
| K982767 | RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR | Raichem | 1998-09-21 | Traditional | PDF ↗ |
| K982501 | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 | Alko Diagnostic Corp. | 1998-09-01 | Traditional | PDF ↗ |
| K981706 | AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 | Abbott Laboratories | 1998-07-09 | Traditional | PDF ↗ |
| K981795 | CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO | Thermo Bioanalysis Corp. | 1998-06-12 | Traditional | PDF ↗ |
| K981305 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR | Olympus America, Inc. | 1998-05-07 | Traditional | PDF ↗ |
| K981436 | DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 | Casco Standards | 1998-04-24 | Special | PDF ↗ |
| K974825 | BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS | Boehringer Mannheim Corp. | 1998-01-30 | Traditional | PDF ↗ |
| K974290 | MICROPROTEIN STANDARD KIT | Verichem Laboratories, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K973932 | BECKMAN CALIBRATOR 2 (CAL2) | Beckman Instruments, Inc. | 1997-12-15 | Traditional | PDF ↗ |
| K973928 | BECKMAN URINE PROTEIN CALIBRATOR (UCAL) | Beckman Instruments, Inc. | 1997-12-01 | Traditional | PDF ↗ |
| K973345 | MATRIX PLUS MULTI-CALIBRATOR KIT | Verichem Laboratories, Inc. | 1997-10-29 | Traditional | PDF ↗ |
| K972333 | AMMONIA/IRON STANDARD KIT | Verichem Laboratories, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971283 | SYNCHRON SYSTEMS CAL 5 PLUS | Beckman Instruments, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K971333 | SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD | Beckman Instruments, Inc. | 1997-05-23 | Traditional | PDF ↗ |
| K970921 | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) | Alko Diagnostic Corp. | 1997-04-08 | Traditional | PDF ↗ |
| K964527 | N RHEUMATOLOGY STANDARD SL | Behring Diagnostics, Inc. | 1997-01-15 | Traditional | PDF ↗ |
| K964829 | ELECSYS CALCHECK FSH | Boehringer Mannheim Corp. | 1996-12-16 | Traditional | PDF ↗ |
| K964062 | N PROTEIN STRANDARD SL | Behring Diagnostics, Inc. | 1996-11-21 | Traditional | PDF ↗ |
| K963543 | SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 | Sigma Diagnostics, Inc. | 1996-10-30 | Traditional | PDF ↗ |
| K962269 | CEDIA CARDIAC TDM MULTI-CALS | Boehringer Mannheim Corp. | 1996-10-29 | Traditional | PDF ↗ |
| K963533 | SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 | Sigma Diagnostics, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K962629 | DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR | Casco Standards | 1996-09-13 | Traditional | PDF ↗ |
| K962410 | N PROTEIN STANDARD PY | Behring Diagnostics, Inc. | 1996-07-16 | Traditional | PDF ↗ |
| K962406 | N CRP STANDARD SY | Behring Diagnostics, Inc. | 1996-07-16 | Traditional | PDF ↗ |
| K955489 | CALIBRATION SERUM LEVEL 1 & 2 | Randox Laboratories, Ltd. | 1996-06-21 | Traditional | PDF ↗ |
| K961659 | CEDIA CORE TDM MULTI-CAL | Boehringer Mannheim Corp. | 1996-06-13 | Traditional | PDF ↗ |
| K960103 | DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS | Dade Intl., Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960085 | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS | Alko Diagnostic Corp. | 1996-03-11 | Traditional | PDF ↗ |
| K955154 | CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT | Alko Diagnostic Corp. | 1995-12-11 | Traditional | PDF ↗ |
| K953979 | APOLIPOPROTEIN CALIBRATOR (APO-CAL) | Beckman Instruments, Inc. | 1995-10-03 | Traditional | PDF ↗ |
| K942706 | ROCHE CALIBRATOR SERUM | Roche Diagnostic Systems, Inc. | 1995-09-20 | Traditional | PDF ↗ |
| K952282 | ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR | Roche Diagnostic Systems, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K953863 | HICHEM ISE STANDARDS KIT 70011 | Hichem Diagnostics | 1995-09-06 | Traditional | PDF ↗ |
| K945966 | ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS | Alko Diagnostic Corp. | 1995-02-10 | Traditional | PDF ↗ |
| K944922 | ALKO CAL PACKS FOR CORNING 654 ANALYZERS | Alko Diagnostic Corp. | 1995-02-10 | Traditional | PDF ↗ |
| K943012 | CALIBRATOR | Prisma Systems | 1994-11-28 | Traditional | PDF ↗ |
| K944639 | DOCUMENTR AMMONIA/ETHANOLCALIBRATOR | Casco Standards | 1994-11-15 | Traditional | PDF ↗ |
| K940760 | FLUIDS PACK FOR CORING 238 | Alko Diagnostic Corp. | 1994-09-06 | Traditional | PDF ↗ |
| K941219 | DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR | Dupont Medical Products | 1994-08-09 | Traditional | PDF ↗ |
| K942549 | ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS | Alko Diagnostic Corp. | 1994-07-28 | Traditional | PDF ↗ |
| K940571 | SYNERMEDIR CAL I AND SYNERMED IR CAL II | Synermed, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K934607 | ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM | Alko Diagnostic Corp. | 1994-03-28 | Traditional | PDF ↗ |
| K935543 | ACA PLUS FERRITIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K933383 | REAGENTS FOR HITACHI ISE | Alko Diagnostic Corp. | 1994-03-09 | Traditional | PDF ↗ |
| K935547 | CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER | Alko Diagnostic Corp. | 1994-01-18 | Traditional | PDF ↗ |
| K935018 | REAGENTS FOR ORION 1020, AND RELATED ANALYZERS | Alko Diagnostic Corp. | 1994-01-18 | Traditional | PDF ↗ |
| K930231 | ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS | Alko Diagnostic Corp. | 1994-01-13 | Traditional | PDF ↗ |
| K925464 | CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR | Alko Diagnostic Corp. | 1994-01-13 | Traditional | PDF ↗ |
| K930199 | ALKO FLUIDS PACKS FOR NOVA ANALYZERS | Alko Diagnostic Corp. | 1994-01-13 | Traditional | PDF ↗ |
| K925385 | REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) | Alko Diagnostic Corp. | 1994-01-13 | Traditional | PDF ↗ |
| K932623 | QUANTIMETRIX BLOOD GLUCOSE CONTROLS | Quantimetrix Corp. | 1993-12-09 | Traditional | PDF ↗ |
| K934701 | REAGENTS FOR COBAS ISE MODULE | Alko Diagnostic Corp. | 1993-12-02 | Traditional | PDF ↗ |
| K934143 | N-ASSAY TIA MICROALBUMIN CALIBRATOR SET | Crestat Diagnostics, Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K932768 | CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 | Helena Laboratories | 1993-10-18 | Traditional | PDF ↗ |
| K933693 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 | Sigma Chemical Co. | 1993-10-13 | Traditional | PDF ↗ |
| K933955 | DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM | E.I. Dupont DE Nemours & Co., Inc. | 1993-10-13 | Traditional | PDF ↗ |
| K933702 | SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 | Sigma Chemical Co. | 1993-10-08 | Traditional | PDF ↗ |
| K930104 | ACE CLINICAL CHEMISTRY SYSTEM | Schiapparelli Biosystems, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K925101 | SYSTEMATE PLUS CALIBRATOR | Em Diagnostic Systems, Inc. | 1993-02-23 | Traditional | PDF ↗ |
| K926518 | ISE CALIBRATOR FOR DUPONT DIMENSION | Alko Diagnostic Corp. | 1993-01-28 | Traditional | PDF ↗ |
| K922043 | ROCHE CALIBRATOR SERUM | Roche Diagnostic Systems, Inc. | 1992-06-16 | Traditional | PDF ↗ |
| K921678 | CIBA CORNING ACS FOLATE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-06-09 | Traditional | PDF ↗ |
| K915797 | CALIBRATOR | Alko Diagnostic Corp. | 1992-01-30 | Traditional | PDF ↗ |
| K914909 | IL TEST(TM) CALIBRATION SET SP | Instrumentation Laboratory CO | 1992-01-22 | Traditional | PDF ↗ |
| K914917 | DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1991-12-13 | Traditional | PDF ↗ |
| K914750 | ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR | Roche Diagnostic Systems, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K910309 | PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION | Baxter Healthcare Corp | 1991-03-29 | Traditional | PDF ↗ |
| K904767 | ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR | Analytical Control Systems, Inc. | 1990-12-26 | Traditional | PDF ↗ |
| K903913 | PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II | Baxter Healthcare Corp | 1990-09-27 | Traditional | PDF ↗ |
| K903888 | HI CHEM PROTEIN/LIPIDS LINEARITY | Hichem Diagnostics | 1990-09-27 | Traditional | PDF ↗ |
| K902675 | MULTI ANALYTE MIXTURE, CALIBRATORS | Phoenix Diagnostics, Inc. | 1990-07-31 | Traditional | PDF ↗ |
| K897097 | COBAS READY CALIBRATOR KIT | Roche Diagnostic Systems, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K897177 | CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE | Nova Biomedical Corp. | 1990-03-27 | Traditional | PDF ↗ |
| K897071 | ROCHE STANDARDS FOR THE COBAS ISE MODULE | Roche Diagnostic Systems, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K895717 | SODIUM AND POTASSIUM STANDARD | Data Medical Associates, Inc. | 1990-01-11 | Traditional | PDF ↗ |
| K895135 | HI CHEM CALIBRATOR A+ | Hichem Diagnostics | 1989-10-23 | Traditional | PDF ↗ |
| K890583 | HI CHEM CALIBRATION STANDARDS LEVELS 1 AND 2 | Hichem Diagnostics | 1989-03-13 | Traditional | PDF ↗ |
| K884693 | UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS | Biomedical Research & Development Laboratories, Inc. | 1988-12-15 | Traditional | PDF ↗ |
| K884227 | CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM | A-Kem, Inc. | 1988-12-09 | Traditional | PDF ↗ |
| K875285 | MULTI-CHEMISTRY LINEARITY STANDARD | Verichem Laboratories, Inc. | 1988-09-02 | Traditional | PDF ↗ |
| K882258 | DC-LIQUICAL CATALOGUE #SE-030 | Diagnostic Chemicals, Ltd. (Usa) | 1988-08-30 | Traditional | PDF ↗ |
| K882116 | TOTAL PROTEIN/ALBUMIN STANDARD | Verichem Laboratories, Inc. | 1988-06-24 | Traditional | PDF ↗ |
| K881258 | PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II | Baxter Healthcare Corp | 1988-05-27 | Traditional | PDF ↗ |
Product code JIX · Class II · Clinical Chemistry. Data: openFDA.