FDA product code GRY: Antigens, All, Leptospira Spp.
GRY is the FDA product code for antigens, all, leptospira spp.. It is a Class II device, regulated under 21 CFR 866.3350 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GRY, from 2 different applicants. The average 510(k) review took 106 days (median 106).
Classification
| Field | Value |
|---|---|
| Device name | Antigens, All, Leptospira Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3350 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRY clearance
Top GRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Panbio, Inc. | 1 | 2000-11-22 |
| Hillcrest Biologicals | 1 | 1988-04-12 |
Most recent GRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K002024 | Panbio, Inc. | PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA | 2000-11-22 | 142 |
| K880417 | Hillcrest Biologicals | LEPTOSPIROSIS IHA | 1988-04-12 | 71 |
Recalls for GRY devices
openFDA lists no recalls for product code GRY.
Frequently asked questions
What is FDA product code GRY?
GRY is the FDA product code for antigens, all, leptospira spp.. It is a Class II device, regulated under 21 CFR 866.3350 and reviewed by the Microbiology panel.
What device class is GRY?
Class II, regulation 21 CFR 866.3350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRY?
Across 2 cleared submissions the average was 106 days from receipt to decision (median 106).
Which companies have the most GRY clearances?
Panbio, Inc. (1); Hillcrest Biologicals (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GRY
- Run a recall and safety report across every GRY manufacturer
- Watch product code GRY 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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