GIL
8 FDA 510(k) clearances · Product code
244 daysmedian time to decision
529 days90th percentile
8clearances measured
FDA profile
- Official device name
- Plasma, Fibrinogen Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7340
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| N/T PROTEIN CONTROL PY (K962407) | Behring Diagnostics, Inc. | 1996-07-29 |
| FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (K946265) | Clinical Controls, Inc. | 1995-08-24 |
| FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (K946193) | More Diagnostics | 1995-08-24 |
| PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (K935598) | Clinical Controls, Inc. | 1995-05-02 |
| N/T PROTEIN CONTROL PY (K951012) | Behring Diagnostics, Inc. | 1995-04-17 |
| LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (K934741) | Clinical Controls, Inc. | 1994-09-08 |
| FIBRINOGEN CONTROL (K915462) | Sigma Diagnostics, Inc. | 1992-03-04 |
| GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL (K833352) | Warner-Lambert Co. | 1983-11-03 |
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Every clearance here is in the API, with alerts when new ones post.