FDA product code GMY: Antisera, Fluorescent, All Types, Escherichia Coli
GMY is the FDA product code for antisera, fluorescent, all types, escherichia coli. It is a Class I device, regulated under 21 CFR 866.3255 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GMY, from 2 different applicants. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Types, Escherichia Coli |
| Device class | Class I |
| Regulation | 21 CFR 866.3255 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GMY clearance
Top GMY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pfizer, Inc. | 1 | 1977-06-08 |
| Pfizer Pharmaceuticals | 1 | 1977-05-25 |
Most recent GMY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770833 | Pfizer, Inc. | FLUORETEC-M | 1977-06-08 | 33 |
| K770801 | Pfizer Pharmaceuticals | MICROBIO. PROD. FLUORESCENT ANTIBODY | 1977-05-25 | 23 |
Recalls for GMY devices
openFDA lists no recalls for product code GMY.
Frequently asked questions
What is FDA product code GMY?
GMY is the FDA product code for antisera, fluorescent, all types, escherichia coli. It is a Class I device, regulated under 21 CFR 866.3255 and reviewed by the Microbiology panel.
What device class is GMY?
Class I, regulation 21 CFR 866.3255. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GMY?
Across 2 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most GMY clearances?
Pfizer, Inc. (1); Pfizer Pharmaceuticals (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GMY
- Run a recall and safety report across every GMY manufacturer
- Watch product code GMY 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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