Panels › Immunology › Product code DCN · Class 2
System, Test, C-Reactive Protein
Regulation 866.5270
0510(k)s in 12 months (70 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in DCN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 1988 | K880728 | KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. | DCN |
| Oct 20, 1987 | K872539 | EUROGENETICS CRP ELISA Eurogenetics | DCN |
| Aug 4, 1986 | K860679 | IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN Orion Corp., FI | DCN |
| Feb 26, 1986 | K855057 | LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) Behring Diagnostics, Inc. | DCN |
| Feb 26, 1986 | K854819 | CPR SLIDE EIKEN Syn-Kit, Inc. | DCN |
| May 22, 1984 | K841265 | TAGO DIFFU-GEN C-REACTIVE PROTEIN Tago, Inc. | DCN |
| Mar 23, 1984 | K840699 | CRP SLIDE TEST KIT Difco Laboratories, Inc. | DCN |
| Feb 27, 1984 | K834584 | NABI CRP-Q.S. TEST Intl. Diagnostic, Inc. | DCN |
| Feb 3, 1984 | K834390 | IMMUNO-CRP Immunostics Co., Inc. | DCN |
| Jun 8, 1983 | K831465 | CRP-CHECK Diagnostic Technology, Inc. | DCN |
| May 27, 1983 | K831364 | TESTCORP RA Myo-Tronics Research, Inc. | DCN |
| May 27, 1983 | K831362 | TESTCORP CRP Catheter Technology Corp. | DCN |
| Jul 2, 1982 | K821388 | SERO/TEX CRP TEST Texas Immunology, Inc. | DCN |
| May 28, 1982 | K821413 | EMIT C-REACTIVE PROTEIN ASSAY Syva Co. | DCN |
| Oct 26, 1981 | K812881 | IMMUNEX CRP Armkel, LLC | DCN |
| Jun 12, 1981 | K811374 | BI-CRP LATEX TEST Biologics Intl., Inc. | DCN |
| Apr 8, 1981 | K810862 | CRP SLIDE Syn-Kit, Inc. | DCN |
| Aug 3, 1979 | K790716 | ANTISERUM TO HUMAN C-REACTIVE PROTEINS Kent Laboratories, Inc. | DCN |
| Sep 2, 1977 | K771535 | LAS-R HUMAN CRP TEST Hyland Therapeutic Div., Travenol Laboratories | DCN |
| Jul 14, 1977 | K771139 | CRP-WELLCOTEST Burroughs Wellcome Co. | DCN |
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