JKD
10 FDA 510(k) clearances · Product code
124 daysmedian time to decision
298 days90th percentile
10clearances measured
FDA profile
- Official device name
- Radioimmunoassay, C-Peptides Of Proinsulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1135
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2011: 13
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 |
|---|---|---|
| AIA-PACK CPR ASSAY (K951848) | Tosoh Medics, Inc. | 1996-02-13 |
| IMMULITE C-PEPTIDE (K943767) | Diagnostic Products Corp. | 1995-03-23 |
| DSL C-PEPTIDE RIA (DSL #7000) (K896420) | Diagnostic Systems Laboratories, Inc. | 1990-05-24 |
| DOUBLE ANTIBODY C-PEPTIDE RIA KIT (K854066) | Diagnostic Products Corp. | 1985-11-12 |
| C-PEP-RIA-100 (K842267) | Institut National Des Radioelements | 1984-09-06 |
| C-PEPTIDE RADIOIMMUNOASSAY TEST KIT (K833396) | Serono Diagnostics, Inc. | 1984-04-13 |
| HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. (K820666) | Immuno Nuclear Corp. | 1982-07-13 |
| RIA QUANT C-PEPTIDE KIT (K812689) | Mallinckrodt Critical Care | 1981-10-06 |
| HUMAN C-PEPTIDE REAGENTS (K812288) | Immunex Radiochemical Diagnostics | 1981-08-31 |
| C-PEPTICE REAGENTS (K810718) | Calbiochem-Behring Corp. | 1981-03-31 |
Track JKD automatically
Every clearance here is in the API, with alerts when new ones post.