Panels › Hematology › Product code GIL · Class 2
Plasma, Fibrinogen Control
Regulation 864.7340
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GIL
| Company | 510(k)s | Recalls |
|---|---|---|
| Clinical Controls, Inc. | 3 | 0 |
| Behring Diagnostics, Inc. | 2 | 0 |
| More Diagnostics | 1 | 0 |
| Sigma Diagnostics, Inc. | 1 | 0 |
| Warner-Lambert Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 29, 1996 | K962407 | N/T PROTEIN CONTROL PY Behring Diagnostics, Inc. | GIL |
| Aug 24, 1995 | K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 Clinical Controls, Inc. | GIL |
| Aug 24, 1995 | K946193 | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 More Diagnostics | GIL |
| May 2, 1995 | K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 Clinical Controls, Inc. | GIL |
| Apr 17, 1995 | K951012 | N/T PROTEIN CONTROL PY Behring Diagnostics, Inc. | GIL |
| Sep 8, 1994 | K934741 | LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 Clinical Controls, Inc. | GIL |
| Mar 4, 1992 | K915462 | FIBRINOGEN CONTROL Sigma Diagnostics, Inc. | GIL |
| Nov 3, 1983 | K833352 | GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL Warner-Lambert Co. | GIL |
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