FDA product code GNY: Antisera, Fluorescent, Adenovirus 1-33
GNY is the FDA product code for antisera, fluorescent, adenovirus 1-33. It is a Class I device, regulated under 21 CFR 866.3020 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under GNY, from 3 different applicants. The average 510(k) review took 73 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Adenovirus 1-33 |
| Device class | Class I |
| Regulation | 21 CFR 866.3020 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GNY clearance
Top GNY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Flow Laboratories, Inc. | 2 | 1977-05-20 |
| Light Diagnostics | 1 | 1993-01-06 |
| Whittaker Bioproducts, Inc. | 1 | 1989-02-16 |
Most recent GNY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922801 | Light Diagnostics | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY | 1993-01-06 | 210 |
| K885310 | Whittaker Bioproducts, Inc. | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG | 1989-02-16 | 49 |
| K770811 | Flow Laboratories, Inc. | ADENOVIRUS GROUP-FA LABELLED PRESERUM | 1977-05-20 | 17 |
| K770807 | Flow Laboratories, Inc. | ADENOVIRUS-GROUP FA LABELLED (8-651 RF) | 1977-05-20 | 17 |
Recalls for GNY devices
openFDA lists no recalls for product code GNY.
Frequently asked questions
What is FDA product code GNY?
GNY is the FDA product code for antisera, fluorescent, adenovirus 1-33. It is a Class I device, regulated under 21 CFR 866.3020 and reviewed by the Microbiology panel.
What device class is GNY?
Class I, regulation 21 CFR 866.3020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GNY?
Across 4 cleared submissions the average was 73 days from receipt to decision (median 33).
Which companies have the most GNY clearances?
Flow Laboratories, Inc. (2); Light Diagnostics (1); Whittaker Bioproducts, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GNY
- Run a recall and safety report across every GNY manufacturer
- Watch product code GNY 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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