FDA product code GGL: Control, White-Cell
GGL is the FDA product code for control, white-cell. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 8 510(k) submissions under GGL, from 4 different applicants. The average 510(k) review took 106 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Control, White-Cell |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GGL clearance
Top GGL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Streck Laboratories, Inc. | 4 | 1999-11-26 |
| Streck | 2 | 2009-02-11 |
| Coulter Corp. | 1 | 1989-09-13 |
| Elite Diagnostic , Ltd. | 1 | 1989-04-10 |
Most recent GGL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083926 | Streck | CD4 COUNT | 2009-02-11 | 42 |
| K051633 | Streck | CD-CHEX PLUS BC | 2005-08-16 | 57 |
| K993126 | Streck Laboratories, Inc. | CD-CHEX CD 34 | 1999-11-26 | 67 |
| K960894 | Streck Laboratories, Inc. | CD-CHEX + RBC | 1996-05-24 | 80 |
| K931825 | Streck Laboratories, Inc. | CD-CHEX CD4 LOW | 1994-06-06 | 426 |
Recalls for GGL devices
openFDA lists no recalls for product code GGL.
Frequently asked questions
What is FDA product code GGL?
GGL is the FDA product code for control, white-cell. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is GGL?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGL?
Across 8 cleared submissions the average was 106 days from receipt to decision (median 62).
Which companies have the most GGL clearances?
Streck Laboratories, Inc. (4); Streck (2); Coulter Corp. (1); Elite Diagnostic , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GGL
- Run a recall and safety report across every GGL manufacturer
- Watch product code GGL 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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