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 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K821813 | BECKMAN URIC ACID STANDARD | Beckman Instruments, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K821061 | ACE ALBUMIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1982-05-03 | Traditional | PDF ↗ |
| K820698 | SYVA ADVANCE STANDARDIZATION KIT 01 | Syva Co. | 1982-04-01 | Traditional | PDF ↗ |
| K813447 | SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR | Rna Medical Corp. | 1981-12-31 | Traditional | PDF ↗ |
| K813505 | FLAME PHOTOMETER CALIBRATION STANDARDS | Fisher Scientific Co., LLC | 1981-12-31 | Traditional | PDF ↗ |
| K813478 | TRIGLYCERIDE CALIBRATORS | Gilford Diagnostics | 1981-12-22 | Traditional | PDF ↗ |
| K812861 | CHOLESTEROL CALIBRATORS | Gilford Diagnostics | 1981-10-23 | Traditional | PDF ↗ |
| K810963 | BIO SET TM SUBSTRATE CALIBRATORS | Boehringer Mannheim Corp. | 1981-04-17 | Traditional | PDF ↗ |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | Pcl-Ria, Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K810742 | AQUEOUS TRIOLEIN STANDARDS & KITS | Supelco, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810618 | AMPULED FLAME PHOTOMETER STANDARDS | United Diagnostics, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810743 | LECITHIN-SPINGOMYELIN STAND. & KITS | Supelco, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810587 | EMIT-TFG PRISMA THYROXINE CALIBRATORS | Syva Co. | 1981-03-24 | Traditional | PDF ↗ |
| K810092 | CHOLESTEROL STANDARD | Anco Medical Reagents & Assoc. | 1981-02-02 | Traditional | PDF ↗ |
| K810091 | GLUCOSE STANDARD | Anco Medical Reagents & Assoc. | 1981-01-26 | Traditional | PDF ↗ |
| K802631 | CREATININE STANDARDS | Gilford Diagnostics | 1980-12-11 | Traditional | PDF ↗ |
| K801501 | UV URIC ACID STANDARDS | The Dow Chemical Co. | 1980-09-26 | Traditional | PDF ↗ |
| K801665 | SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) | Miles Laboratories, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K801287 | EMIT AAII THYROXINE CALIBRATORS | Syva Co. | 1980-06-30 | Traditional | PDF ↗ |
| K800588 | NSI CALIBRATOR SET | Nobel Scientific Industries, Inc. | 1980-04-04 | Traditional | PDF ↗ |
| K800206 | ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. | E.I. Dupont DE Nemours & Co., Inc. | 1980-03-03 | Traditional | PDF ↗ |
| K800062 | PIPET CALIBRATION KIT | Streck Laboratories, Inc. | 1980-02-11 | Traditional | PDF ↗ |
| K800042 | LITHIUM STANDARD (1MM/L) | Gilford Diagnostics | 1980-01-21 | Traditional | PDF ↗ |
| K792046 | URIC ACID STANDARD | Gilford Diagnostics | 1979-10-30 | Traditional | PDF ↗ |
| K791315 | SPECTRO-SUR SET | Helena Laboratories | 1979-08-16 | Traditional | PDF ↗ |
| K781853 | CHOLESTEROL STANDARDS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-12-04 | Traditional | PDF ↗ |
| K780467 | EMIT ANTIEPILEPTIC DRUG CALIBRATORS | Syva Co. | 1978-04-24 | Traditional | PDF ↗ |
| K772025 | URIC ACID STD. FOR QUANT. URIC ACID | Worthington Biochemical Corp. | 1977-11-11 | Traditional | PDF ↗ |
| K770072 | BIO TROL-T TRIOLEIN SOLUTIONS | Boehringer Mannheim Corp. | 1977-01-26 | Traditional | PDF ↗ |
| K760806 | REFEREE AQUEOUS TRIGLYCERIDE STND | Analytical Products, Inc. | 1976-10-21 | Traditional | PDF ↗ |
Product code JIS · Class II · Clinical Chemistry. Data: openFDA.