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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K030772 | RDI EXTENDED RANGE CRP CALIBRATOR SET | Reference Diagnostics, Inc. | 2003-04-11 | Abbreviated | PDF ↗ |
| K022533 | FASTPACK TESTOSTERONE CALIBRATOR | Qualigen, Inc. | 2002-09-30 | Abbreviated | PDF ↗ |
| K022027 | CALIBRATING MATERIAL, BUFFERS, STANDARD | Mission Diagnostics | 2002-07-22 | Traditional | PDF ↗ |
| K021607 | RDI HS CRP CALIBRATOR SET | Reference Diagnostics, Inc. | 2002-06-27 | Abbreviated | PDF ↗ |
| K021535 | ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR | Bayer Diagnostics Corp. | 2002-06-27 | Traditional | PDF ↗ |
| K021532 | ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR | Bayer Diagnostics Corp. | 2002-06-27 | Traditional | PDF ↗ |
| K020980 | DIMENSION TPSA CALIBRATOR, MODEL #RC459 | Dade Behring, Inc. | 2002-06-21 | Traditional | PDF ↗ |
| K020723 | DIMENSION ALDL CALIBRATOR, MODEL DC131 | Dade Behring, Inc. | 2002-05-08 | Traditional | PDF ↗ |
| K020894 | CALIBRATING MATERIAL, CAL-PAK, BUFFERS | Mission Diagnostics | 2002-04-29 | Traditional | PDF ↗ |
| K020454 | CHEMISTRY CALIBRATOR | Jas Diagnostics, Inc. | 2002-04-08 | Traditional | PDF ↗ |
| K020596 | CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS | Diamond Diagnostics, Inc. | 2002-03-23 | Traditional | PDF ↗ |
| K013850 | STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE | Diamond Diagnostics, Inc. | 2001-12-21 | Traditional | PDF ↗ |
| K012900 | ACCESS UNCONJUGATED ESTRIOL CALIBRATORS | Beckman Coulter, Inc. | 2001-10-16 | Traditional | PDF ↗ |
| K012367 | VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D | Nichols Institute Diagnostics | 2001-10-09 | Traditional | PDF ↗ |
| K012233 | STRATUS CS TROPONIN I CALIBRATOR | Dade Behring, Inc. | 2001-09-11 | Traditional | PDF ↗ |
| K012399 | MODIFICATION TO ELECSYS FSH II CALSET | Roche Diagnostics Corp. | 2001-08-24 | Special | PDF ↗ |
| K010332 | WAKO IMMUNOASSAY CALIBRATOR SET | Wako Chemicals USA, Inc. | 2001-08-01 | Traditional | PDF ↗ |
| K010334 | WAKO LIPID CALIBRATOR | Wako Chemicals USA, Inc. | 2001-06-25 | Traditional | PDF ↗ |
| K011126 | RAICHEM CREATININE URINE STANDARD | Hemagen Diagnostics, Inc. | 2001-05-02 | Special | PDF ↗ |
| K010314 | DIMENSION CTNI CALIBRATOR | Dade Behring, Inc. | 2001-04-20 | Traditional | PDF ↗ |
| K003501 | N PROTEIN STANDARD UY CALIBRATOR | Dade Behring, Inc. | 2001-03-15 | Traditional | PDF ↗ |
| K003411 | ELECSYS TESTOSTERONE CALSET II | Roche Diagnostics Corp. | 2001-03-01 | Abbreviated | PDF ↗ |
| K010208 | DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 | Dade Behring, Inc. | 2001-02-20 | Traditional | PDF ↗ |
| K003409 | ELECSYS FSH CALSET II | Roche Diagnostics Corp. | 2001-01-26 | Abbreviated | PDF ↗ |
| K003096 | FASTPACK CALIBRATORS | Qualigen, Inc. | 2000-11-30 | Abbreviated | PDF ↗ |
| K003098 | ACCESS ULTRASENSITIVE HGH CALIBRATORS | Beckman Coulter, Inc. | 2000-11-20 | Traditional | PDF ↗ |
| K000783 | DIRECT TIBC CALIBRATOR | Reference Diagnostics, Inc. | 2000-05-04 | Abbreviated | PDF ↗ |
| K994291 | DIMENSION SPECIAL PROTEIN CALIBRATOR | Dade Behring, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K993132 | GENZYME DIRECT AMYLASE VERIFIER | Genzyme Corp. | 1999-10-04 | Abbreviated | PDF ↗ |
| K992981 | ELECSYS ESTRADIOL CALSET II | Roche Diagnostics Corp. | 1999-09-24 | Traditional | PDF ↗ |
| K991705 | N PROTEIN STANDARD UY | Dade Behring, Inc. | 1999-07-15 | Traditional | PDF ↗ |
| K991176 | OPUS TROPONIN I CALIBRATOR | Dade Behring, Inc. | 1999-07-01 | Traditional | PDF ↗ |
| K990824 | REVISED C-REACTIVE PROTEIN CALIBRATOR | Dade Behring, Inc. | 1999-04-16 | Traditional | PDF ↗ |
| K990554 | DIMENSION SPECIAL PROTEIN CALIBRATOR | Dade Behring, Inc. | 1999-03-22 | Traditional | PDF ↗ |
| K984193 | DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR | Dade Behring, Inc. | 1998-12-14 | Traditional | PDF ↗ |
| K983850 | DIMENSION AHDL CALIBRATOR | Dade Behring, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983693 | DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR | Dade Behring, Inc. | 1998-11-04 | Traditional | PDF ↗ |
| K983722 | STRATUS CS TROPONIN I CALIBRATOR | Dade Behring, Inc. | 1998-11-04 | Traditional | PDF ↗ |
| K983548 | FERRITIN CALIBRATOR | Dade Behring, Inc. | 1998-10-27 | Traditional | PDF ↗ |
| K981854 | OLYMPUS SERUM PROTEIN MULTICALIBRATOR, | Olympus Diagnostica GmbH | 1998-08-18 | Traditional | PDF ↗ |
| K982292 | PREALBUMIN CALIBRATOR | Dade Behring, Inc. | 1998-08-13 | Traditional | PDF ↗ |
| K981100 | STRATUS CS TROP CALPAK | Dade Behring, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K981097 | STRATUS CS CKMB CALPAK | Dade Behring, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K981101 | STRATUS CS MYO CALPAK | Dade Behring, Inc. | 1998-04-15 | Traditional | PDF ↗ |
| K973668 | CARDIAC TROPONIN-I (TROP) CALIBRATOR | Dade Intl., Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K973100 | PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR | Dade Chemistry Systems, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K964368 | ELECSYS CEA ASSAY | Boehringer Mannheim Corp. | 1997-06-16 | Traditional | PDF ↗ |
| K970336 | MMB CALIBRATOR | Dade Chemistry Systems, Inc. | 1997-03-03 | Traditional | PDF ↗ |
| K970389 | THYROID CALIBRATOR | Dade Chemistry Systems, Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K963493 | FERRITIN CALIBRATOR | Dade Chemistry Systems, Inc. | 1996-12-03 | Traditional | PDF ↗ |
| K962594 | ACA PLUS FT4 CALIBRATOR | Dade Intl., Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K954326 | STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY | Solarcare Technologies Corp,Inc. | 1996-07-23 | Traditional | PDF ↗ |
| K952815 | DUPONT LIPASE CALIBRATOR | Dupont Medical Products | 1995-08-31 | Traditional | PDF ↗ |
| K944516 | FLUIDS PACK | Alko Diagnostic Corp. | 1994-11-02 | Traditional | PDF ↗ |
| K943704 | LIPASE CALIBRATOR | The DU Pont Co. | 1994-09-14 | Traditional | PDF ↗ |
| K934843 | URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K913371 | TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL | Creative Laboratory Products, Inc. | 1991-11-08 | Traditional | PDF ↗ |
| K910962 | CHOLESTEROL CALIBRATOR SET | Casco Standards | 1991-03-29 | Traditional | PDF ↗ |
| K910160 | ELECTROPHORESIS CONTROL | Seradyn, Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K904698 | SECONDARY CALIBRATORS | Bionostics, Inc. | 1990-11-28 | Traditional | PDF ↗ |
| K895649 | COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. | Ventrex Laboratories, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K895648 | COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. | Ventrex Laboratories, Inc. | 1990-01-18 | Traditional | PDF ↗ |
| K892329 | OSMOMETER STANDARD SOLUTIONS | D.R.G. Scientific Industries | 1989-10-31 | Traditional | PDF ↗ |
| K891999 | CHLORIDE STANDARDS ITEM #SR1041 | Em Diagnostic Systems, Inc. | 1989-08-15 | Traditional | PDF ↗ |
| K893139 | DOCUMENT(TM) URIC ACID LINEARITY TEST SET | Casco Standards | 1989-07-20 | Traditional | PDF ↗ |
| K884197 | DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET | Casco Standards | 1988-12-14 | Traditional | PDF ↗ |
| K882059 | BILIRUBIN STANDARD | Verichem Laboratories, Inc. | 1988-10-25 | Traditional | PDF ↗ |
| K883306 | BINAS LUTEINIZING HORMONE IRMA TEST KIT | Binax, Inc. | 1988-10-06 | Traditional | PDF ↗ |
| K882259 | DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 | Diagnostic Chemicals, Ltd. (Usa) | 1988-07-21 | Traditional | PDF ↗ |
| K873743 | PARAMAX ISE CHLORIDE CALIBRATOR | Baxter Healthcare Corp | 1987-12-14 | Traditional | PDF ↗ |
| K871759 | G-GT STANDARD CALIBRATOR | Wako Chemicals USA, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K872073 | BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052 | American Monitor Corp. | 1987-09-11 | Traditional | PDF ↗ |
| K872451 | BILE ACIDS CALIBRATOR | Sigma Diagnostics, Inc. | 1987-08-21 | Traditional | PDF ↗ |
| K872263 | TOTAL BILIRUBIN STANDARD CALIBRATOR | Wako Chemicals USA, Inc. | 1987-07-22 | Traditional | PDF ↗ |
| K871756 | CREATININE STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-27 | Traditional | PDF ↗ |
| K871762 | MAGNESIUM STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871765 | PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871768 | URIC ACID STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871763 | NEFA STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871758 | GLUCOSE STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871767 | UREA N STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871764 | INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871150 | ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 | Beckman Instruments, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K871766 | TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR | Wako Chemicals USA, Inc. | 1987-05-26 | Traditional | PDF ↗ |
| K870673 | ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1987-03-19 | Traditional | PDF ↗ |
| K862525 | EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95 | Em Diagnostic Systems, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K861314 | CHOLESTEROL CALIBRATORS | Sigma Diagnostics, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K854784 | ABSORBANCE (ABS) TEST PAK | Diagnostic Systems | 1985-12-19 | Traditional | PDF ↗ |
| K853887 | LIQUI-SERA CHEM. MULTIPLE CALIBRATORS | Biodiagnostic Intl | 1985-09-30 | Traditional | PDF ↗ |
| K853533 | ABSORBANCE TEST SOLUTION | Diagnostic Systems | 1985-09-16 | Traditional | PDF ↗ |
| K852461 | CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET | Medical Analysis Systems, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K852067 | DIRECT BILIRUBEN CALIBRATIONS | Data Medical Associates, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K851670 | CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ | Medical Analysis Systems, Inc. | 1985-05-10 | Traditional | PDF ↗ |
| K844468 | TRIGLYCERIDE CALIBRATOR | Sigma Diagnostics, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K844047 | FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS | Fisher Diagnostics | 1984-11-09 | Traditional | PDF ↗ |
| K843112 | ROCHE STANDARDS FOR URIC ACID | Roche Diagnostic Systems, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K842099 | ACTH STANDARD MATRIX | Diagnostic Systems Laboratories, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K840771 | ALCOHOL & AMMONIA CALIBRATOR I | American Dade | 1984-04-13 | Traditional | PDF ↗ |
| K840772 | ALCOHOL & AMMONIA CALIBRATOR II | American Dade | 1984-04-13 | Traditional | PDF ↗ |
| K840774 | CARBON DIOXIDE CALIBRATOR I | American Dade | 1984-04-04 | Traditional | PDF ↗ |
Product code JIT · Class II · Clinical Chemistry. Data: openFDA.