Panels › Clinical Chemistry › Product code JKD · Class 1
Radioimmunoassay, C-Peptides Of Proinsulin
Regulation 862.1135
0510(k)s in 12 months (10 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in JKD
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 0 | 2 |
| Diagnostic Products Corp. | 2 | 0 |
| Tosoh Bioscience Inc | 0 | 2 |
| Calbiochem-Behring Corp. | 1 | 0 |
| Diagnostic Systems Laboratories, Inc. | 1 | 0 |
| DRG International, Inc. | 0 | 1 |
| Immunex Radiochemical Diagnostics | 1 | 0 |
| Immuno Nuclear Corp. | 1 | 0 |
| Institut National Des Radioelements | 1 | 0 |
| Mallinckrodt Critical Care | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 1996 | K951848 | AIA-PACK CPR ASSAY Tosoh Medics, Inc. | JKD |
| Mar 23, 1995 | K943767 | IMMULITE C-PEPTIDE Diagnostic Products Corp. | JKD |
| May 24, 1990 | K896420 | DSL C-PEPTIDE RIA (DSL #7000) Diagnostic Systems Laboratories, Inc. | JKD |
| Nov 12, 1985 | K854066 | DOUBLE ANTIBODY C-PEPTIDE RIA KIT Diagnostic Products Corp. | JKD |
| Sep 6, 1984 | K842267 | C-PEP-RIA-100 Institut National Des Radioelements | JKD |
| Apr 13, 1984 | K833396 | C-PEPTIDE RADIOIMMUNOASSAY TEST KIT Serono Diagnostics, Inc. | JKD |
| Jul 13, 1982 | K820666 | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. Immuno Nuclear Corp. | JKD |
| Oct 6, 1981 | K812689 | RIA QUANT C-PEPTIDE KIT Mallinckrodt Critical Care | JKD |
| Aug 31, 1981 | K812288 | HUMAN C-PEPTIDE REAGENTS Immunex Radiochemical Diagnostics | JKD |
| Mar 31, 1981 | K810718 | C-PEPTICE REAGENTS Calbiochem-Behring Corp. | JKD |
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