FDA Product Code
FDA Product Code CFP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1405
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963911 | ALPCO/MERCODIA INSULIN ELISA | American Laboratory Products Co., Ltd. | 1996-11-01 | Traditional | PDF ↗ |
| K953084 | ACCESS ULTRASENSITIVE INSULIN ASSAY | Bio-Rad Laboratories, Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K920109 | IMX INSULIN | Abbott Laboratories | 1992-05-07 | Traditional | PDF ↗ |
| K914820 | DSL INSULIN RIA (DSL 1600) | Diagnostic Systems Laboratories, Inc. | 1992-01-09 | Traditional | PDF ↗ |
| K903628 | AIA-PACK IRI | Tosoh Corp. | 1990-09-07 | Traditional | PDF ↗ |
| K901135 | ENZYMUN TEST(R) INSULIN | Boehringer Mannheim Corp. | 1990-04-03 | Traditional | PDF ↗ |
| K896572 | REP(TM) SPE PLUS-30 PROCEDURES | Helena Laboratories | 1990-01-11 | Traditional | PDF ↗ |
| K890837 | RIA-GNOST INSULIN | Cambridge Medical Technology | 1989-04-26 | Traditional | PDF ↗ |
| K851071 | PHARMACIA INSULIN RIA | Pharmacia, Inc. | 1985-04-12 | Traditional | PDF ↗ |
| K841573 | INSULIN RADIOIMMUNOASSAY KIT | Sorin Biomedica, Fiat, USA, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K823939 | WAKO INSULIN TEST | Wako Chemicals USA, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K822509 | COVALENT COAT RIA KIT | Immuchem Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K821861 | COAT-A-COUNT INSULIN KIT | Diagnostic Products Corp. | 1982-07-08 | Traditional | PDF ↗ |
| K821374 | ENZYMUNE-TEST INSULIN | Icl Scientific | 1982-05-28 | Traditional | PDF ↗ |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Clinical Assays, Inc. | 1981-09-24 | Traditional | PDF ↗ |
| K811953 | IMMOPHASE INSULIN (125I) RADIOASSAY | Corning Medical & Scientific | 1981-07-23 | Traditional | PDF ↗ |
| K811423 | VENTRE/SEP | Ventrex Laboratories, Inc. | 1981-06-09 | Traditional | PDF ↗ |
| K811144 | ARIA II INSULIN RIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-15 | Traditional | PDF ↗ |
| K792279 | AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM | Micromedic Systems | 1979-12-06 | Traditional | PDF ↗ |
| K791707 | CENTRIA INSULIN RIA | Ventrex Laboratories, Inc. | 1979-10-17 | Traditional | PDF ↗ |
| K790630 | RIA, INSULIN, DOUBLE ANTIBODY | Endocrine-Metabolic Center | 1979-07-24 | Traditional | PDF ↗ |
| K781285 | INSULIN RIA KIT | Serono Laboratories, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K781086 | INSULIN AUTOPAK | Micromedic Systems | 1978-08-14 | Traditional | PDF ↗ |
| K771947 | INSULIN RIA MODULE | Inter Science Institute | 1978-01-20 | Traditional | PDF ↗ |
| K772281 | RSL INSULIN KIT | Radioassay Systems Laboratories, Inc. | 1978-01-06 | Traditional | PDF ↗ |
| K771979 | CENTRIA INSULIN RIA | Union Carbide Corp. | 1977-11-17 | Traditional | PDF ↗ |
| K771628 | NSULIN RIA KIT 125I | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-09-20 | Traditional | PDF ↗ |
Product code CFP · Class I · Clinical Chemistry. Data: openFDA.