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 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K840775 | CARBON DIOXIDE CALIBRATOR II | American Dade | 1984-04-04 | Traditional | PDF ↗ |
| K840218 | TRIGLYCERIDE AQUEOUS STANDARDS | Preventive Diagnostics Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K833702 | ACA THYROXINE UPTAKE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1984-01-04 | Traditional | PDF ↗ |
| K833700 | ACA THYROXINE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K832094 | BILIRUBIN CALIBRATORS & CONTROL | Gilford Diagnostics | 1983-08-11 | Traditional | PDF ↗ |
| K830469 | BILIRUBIN STANDARD-LYOPHILIZED | Dow Instruments & Reagents, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K823023 | KM-KAL L6 | Kmn Products, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K823024 | KM - KAL 1 | Kmn Products, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K823020 | KM-KAL 4 | Kmn Products, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K823022 | KM-KAL 6 | Kmn Products, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K823021 | KM - KAL 5 | Kmn Products, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K823025 | KM - KAL 2 | Kmn Products, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K823019 | KM-KAL 3 | Kmn Products, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K822852 | TRIGLYCERIDE CALIBRATOR | Harleco Diagnostics | 1982-10-27 | Traditional | PDF ↗ |
| K822496 | SERA CHEM SMAC CALIBRATORS | Fisher Scientific Co., LLC | 1982-09-21 | Traditional | PDF ↗ |
| K822479 | BILIRUBIN CALIBRATOR #65071 | Emd Chemicals, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822475 | TOTAL PROTEIN STANDARD, #65074 | Emd Chemicals, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822478 | ALBUMIN STANDARD, #65070 | Emd Chemicals, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K822334 | BILIRUBIN CALIBRATORS | Gilford Diagnostics | 1982-09-02 | Traditional | PDF ↗ |
| K802823 | CHOLESTEROL STANDARDS | Mallinckrodt Critical Care | 1980-12-11 | Traditional | PDF ↗ |
| K800770 | SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT | Sclavo, Inc. | 1980-04-21 | Traditional | PDF ↗ |
| K800220 | CALIBRATOR NO. 1 & 2, & WASH SOLUTION | Fisher Scientific Co., LLC | 1980-02-26 | Traditional | PDF ↗ |
| K792290 | TSH STANDARDS & DILUENT | Amersham Corp. | 1979-12-06 | Traditional | PDF ↗ |
| K791312 | CATALOG #4-2520 CHLORIDOMETER CHLORIDE | Buchler Instruments, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K781423 | DUAL COMPONENT STANDARDS | Abbott Laboratories | 1978-08-31 | Traditional | PDF ↗ |
| K781071 | STANDARDS, HORMONE, THYROID STIMULATING | Pcl-Ria, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K781069 | T3 STANDARDS IN HUMAN SERUM | Pcl-Ria, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K781072 | TRAP-BLOOD VESSEL STABILIZATION DEVICE | Ayer, Patrick, M.D. | 1978-08-10 | Traditional | PDF ↗ |
| K780447 | URIC ACID REFERENCE SERA | Macomb Chemical Co. | 1978-06-22 | Traditional | PDF ↗ |
| K780295 | CALIBRATORS, CARBON DIOXIDE | E.I. Dupont DE Nemours & Co., Inc. | 1978-04-05 | Traditional | PDF ↗ |
| K772153 | FLAME PHOTOMETER STANDARD | Alko Scientific Co. | 1978-02-28 | Traditional | PDF ↗ |
| K772106 | PH CALIBRATION BUFFERS | General Diagnostics | 1977-12-06 | Traditional | PDF ↗ |
| K771803 | ACA PHOSPHORUS CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771802 | ACA IRON CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771797 | ACA TRIGLYCERIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771801 | ACA CARBON DIOXIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771804 | ACA AMMONIA CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-25 | Traditional | PDF ↗ |
| K771215 | CENTRIFICHEM TRIGLYCERIDE CALI. STD. | Union Carbide Corp. | 1977-07-21 | Traditional | PDF ↗ |
| K771216 | CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET | Union Carbide Corp. | 1977-07-21 | Traditional | PDF ↗ |
| K771143 | INORGANIC PHOSPHORUS STANDARDS | Worthington Biochemical Corp. | 1977-07-11 | Traditional | PDF ↗ |
| K770277 | CHOLESTEROL STANDARDS | Worthington Biochemical Corp. | 1977-03-01 | Traditional | PDF ↗ |
| K770127 | CENTRIFICHEM 200MG/DL CHOL. CAL. STD. | Union Carbide Corp. | 1977-01-31 | Traditional | PDF ↗ |
| K770126 | CENTRIFICHEM CHOLES. CALIB. STD. SET | Union Carbide Corp. | 1977-01-31 | Traditional | PDF ↗ |
| K761197 | CHOLESTEROL CALIBRATOR | Beckman Instruments, Inc. | 1976-12-21 | Traditional | PDF ↗ |
| K760349 | BILIRUBIN REF., SIGMA STOCK NO. 605-10 | Sigma Chemical Co. | 1976-10-05 | Traditional | PDF ↗ |
Product code JIT · Class II · Clinical Chemistry. Data: openFDA.