FDA product code GIL: Plasma, Fibrinogen Control
GIL is the FDA product code for plasma, fibrinogen control. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel. FDA has cleared 8 510(k) submissions under GIL, from 5 different applicants. The average 510(k) review took 196 days (median 168).
Classification
| Field | Value |
|---|---|
| Device name | Plasma, Fibrinogen Control |
| Device class | Class II |
| Regulation | 21 CFR 864.7340 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GIL clearance
Top GIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clinical Controls, Inc. | 3 | 1995-08-24 |
| Behring Diagnostics, Inc. | 2 | 1996-07-29 |
| More Diagnostics | 1 | 1995-08-24 |
| Sigma Diagnostics, Inc. | 1 | 1992-03-04 |
| Warner-Lambert Co. | 1 | 1983-11-03 |
Most recent GIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962407 | Behring Diagnostics, Inc. | N/T PROTEIN CONTROL PY | 1996-07-29 | 38 |
| K946265 | Clinical Controls, Inc. | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | 1995-08-24 | 244 |
| K946193 | More Diagnostics | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 | 1995-08-24 | 247 |
| K935598 | Clinical Controls, Inc. | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | 1995-05-02 | 529 |
| K951012 | Behring Diagnostics, Inc. | N/T PROTEIN CONTROL PY | 1995-04-17 | 42 |
Recalls for GIL devices
openFDA lists no recalls for product code GIL.
Frequently asked questions
What is FDA product code GIL?
GIL is the FDA product code for plasma, fibrinogen control. It is a Class II device, regulated under 21 CFR 864.7340 and reviewed by the Hematology panel.
What device class is GIL?
Class II, regulation 21 CFR 864.7340. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GIL?
Across 8 cleared submissions the average was 196 days from receipt to decision (median 168).
Which companies have the most GIL clearances?
Clinical Controls, Inc. (3); Behring Diagnostics, Inc. (2); More Diagnostics (1); Sigma Diagnostics, Inc. (1); Warner-Lambert Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GIL
- Run a recall and safety report across every GIL manufacturer
- Watch product code GIL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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