FDA product code GSN: Antiserum, Positive And Negative Febrile Antigen Control Serum
GSN is the FDA product code for antiserum, positive and negative febrile antigen control serum. It is a Class II device, regulated under 21 CFR 866.3085 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under GSN, from 3 different applicants. The average 510(k) review took 118 days (median 71). FDA has posted 2 recalls for GSN devices.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Positive And Negative Febrile Antigen Control Serum |
| Device class | Class II |
| Regulation | 21 CFR 866.3085 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GSN clearance
Top GSN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sa Scientific, Inc. | 1 | 1995-07-18 |
| Investigacion Farmaceutica S.A. DE C.V. | 1 | 1989-08-15 |
| Immuno-Mycologics, Inc. | 1 | 1979-08-16 |
Most recent GSN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952145 | Sa Scientific, Inc. | SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM | 1995-07-18 | 71 |
| K885113 | Investigacion Farmaceutica S.A. DE C.V. | IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL | 1989-08-15 | 246 |
| K791385 | Immuno-Mycologics, Inc. | NEGATIVE CONTROL SERUM FOR CF RO ID | 1979-08-16 | 36 |
Recalls for GSN devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-10-20.
Frequently asked questions
What is FDA product code GSN?
GSN is the FDA product code for antiserum, positive and negative febrile antigen control serum. It is a Class II device, regulated under 21 CFR 866.3085 and reviewed by the Microbiology panel.
What device class is GSN?
Class II, regulation 21 CFR 866.3085. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSN?
Across 3 cleared submissions the average was 118 days from receipt to decision (median 71).
Which companies have the most GSN clearances?
Sa Scientific, Inc. (1); Investigacion Farmaceutica S.A. DE C.V. (1); Immuno-Mycologics, Inc. (1).
Have GSN devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2004-10-20.
Next steps
- Run an FDA pathway report with predicate devices for product code GSN
- Run a recall and safety report across every GSN manufacturer
- Watch product code GSN 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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