FDA product code GGG: Guaiac Reagent
GGG is the FDA product code for guaiac reagent. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GGG. The average 510(k) review took 66 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Guaiac Reagent |
| Device class | Class II |
| Regulation | 21 CFR 864.6550 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GGG clearance
Top GGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marketing Consultants of America | 1 | 1981-11-20 |
Most recent GGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812603 | Marketing Consultants of America | TANARAMA | 1981-11-20 | 66 |
Recalls for GGG devices
openFDA lists no recalls for product code GGG.
Frequently asked questions
What is FDA product code GGG?
GGG is the FDA product code for guaiac reagent. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel.
What device class is GGG?
Class II, regulation 21 CFR 864.6550. Typical premarket route: 510(k).
How long does a 510(k) take for product code GGG?
Across 1 cleared submissions the average was 66 days from receipt to decision (median 66).
Which companies have the most GGG clearances?
Marketing Consultants of America (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GGG
- Run a recall and safety report across every GGG manufacturer
- Watch product code GGG 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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