Panels › Immunology › Product code DGR · Class 1
Whole Human Serum, Antigen, Antiserum, Control
Regulation 866.5700
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DGR
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Instruments, Inc. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Consolidated Technologies, Inc. | 1 | 0 |
| Kallestad Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 1996 | K961544 | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 Consolidated Technologies, Inc. | DGR |
| Sep 5, 1990 | K902220 | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL Boehringer Mannheim Corp. | DGR |
| Jan 9, 1987 | K865014 | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II Bio-Rad | DGR |
| Apr 4, 1979 | K790298 | RADIOASSAY, CONTROL SERUM I, II, III Kallestad Laboratories, Inc. | DGR |
| Aug 31, 1978 | K781355 | ICS NORMAL CONTROL SERUM Beckman Instruments, Inc. | DGR |
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