CFP
27 FDA 510(k) clearances · Product code
30 daysmedian time to decision
95 days90th percentile
27clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Immunoreactive Insulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1405
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2012: 8 · 2025: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALPCO/MERCODIA INSULIN ELISA (K963911) | American Laboratory Products Co., Ltd. | 1996-11-01 |
| ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084) | Bio-Rad Laboratories, Inc. | 1995-09-25 |
| IMX INSULIN (K920109) | Abbott Laboratories | 1992-05-07 |
| DSL INSULIN RIA (DSL 1600) (K914820) | Diagnostic Systems Laboratories, Inc. | 1992-01-09 |
| AIA-PACK IRI (K903628) | Tosoh Corp. | 1990-09-07 |
| ENZYMUN TEST(R) INSULIN (K901135) | Boehringer Mannheim Corp. | 1990-04-03 |
| REP(TM) SPE PLUS-30 PROCEDURES (K896572) | Helena Laboratories | 1990-01-11 |
| RIA-GNOST INSULIN (K890837) | Cambridge Medical Technology | 1989-04-26 |
| PHARMACIA INSULIN RIA (K851071) | Pharmacia, Inc. | 1985-04-12 |
| INSULIN RADIOIMMUNOASSAY KIT (K841573) | Sorin Biomedica, Fiat, USA, Inc. | 1984-05-16 |
| WAKO INSULIN TEST (K823939) | Wako Chemicals USA, Inc. | 1983-01-28 |
| COVALENT COAT RIA KIT (K822509) | Immuchem Corp. | 1982-09-28 |
| COAT-A-COUNT INSULIN KIT (K821861) | Diagnostic Products Corp. | 1982-07-08 |
| ENZYMUNE-TEST INSULIN (K821374) | Icl Scientific | 1982-05-28 |
| GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY (K812227) | Clinical Assays, Inc. | 1981-09-24 |
| IMMOPHASE INSULIN (125I) RADIOASSAY (K811953) | Corning Medical & Scientific | 1981-07-23 |
| VENTRE/SEP (K811423) | Ventrex Laboratories, Inc. | 1981-06-09 |
| ARIA II INSULIN RIA (K811144) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-05-15 |
| AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM (K792279) | Micromedic Systems | 1979-12-06 |
| CENTRIA INSULIN RIA (K791707) | Ventrex Laboratories, Inc. | 1979-10-17 |
| RIA, INSULIN, DOUBLE ANTIBODY (K790630) | Endocrine-Metabolic Center | 1979-07-24 |
| INSULIN RIA KIT (K781285) | Serono Laboratories, Inc. | 1978-08-14 |
| INSULIN AUTOPAK (K781086) | Micromedic Systems | 1978-08-14 |
| INSULIN RIA MODULE (K771947) | Inter Science Institute | 1978-01-20 |
| RSL INSULIN KIT (K772281) | Radioassay Systems Laboratories, Inc. | 1978-01-06 |
| CENTRIA INSULIN RIA (K771979) | Union Carbide Corp. | 1977-11-17 |
| NSULIN RIA KIT 125I (K771628) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-09-20 |
Track CFP automatically
Every clearance here is in the API, with alerts when new ones post.