FDA product code GGJ: Fluid, Diluting, White-Cell
GGJ is the FDA product code for fluid, diluting, white-cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GGJ. The average 510(k) review took 161 days (median 161).
Classification
| Field | Value |
|---|---|
| Device name | Fluid, Diluting, White-Cell |
| Device class | Class I |
| Regulation | 21 CFR 864.8200 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GGJ clearance
Top GGJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1993-06-02 |
Most recent GGJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926422 | Syva Co. | VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY | 1993-06-02 | 161 |
Recalls for GGJ devices
openFDA lists no recalls for product code GGJ.
Frequently asked questions
What is FDA product code GGJ?
GGJ is the FDA product code for fluid, diluting, white-cell. It is a Class I device, regulated under 21 CFR 864.8200 and reviewed by the Hematology panel.
What device class is GGJ?
Class I, regulation 21 CFR 864.8200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GGJ?
Across 1 cleared submissions the average was 161 days from receipt to decision (median 161).
Which companies have the most GGJ clearances?
Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GGJ
- Run a recall and safety report across every GGJ manufacturer
- Watch product code GGJ 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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