FDA product code GOA: Antisera, Cf, Adenovirus 1-33
GOA is the FDA product code for antisera, cf, adenovirus 1-33. It is a Class I device, regulated under 21 CFR 866.3020 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GOA. The average 510(k) review took 73 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Cf, 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 GOA clearance
Top GOA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sita, Inc. | 1 | 1987-09-18 |
Most recent GOA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K872698 | Sita, Inc. | ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN | 1987-09-18 | 73 |
Recalls for GOA devices
openFDA lists no recalls for product code GOA.
Frequently asked questions
What is FDA product code GOA?
GOA is the FDA product code for antisera, cf, 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 GOA?
Class I, regulation 21 CFR 866.3020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GOA?
Across 1 cleared submissions the average was 73 days from receipt to decision (median 73).
Which companies have the most GOA clearances?
Sita, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GOA
- Run a recall and safety report across every GOA manufacturer
- Watch product code GOA 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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