FDA product code GSO: Antigens (Febrile), Agglutination, Brucella Spp.
GSO is the FDA product code for antigens (febrile), agglutination, brucella spp.. It is a Class II device, regulated under 21 CFR 866.3085 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under GSO, from 5 different applicants. The average 510(k) review took 77 days (median 70). FDA has posted 2 recalls for GSO devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigens (Febrile), Agglutination, Brucella Spp. |
| 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 GSO clearance
Top GSO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sa Scientific, Inc. | 7 | 1995-07-18 |
| Lee Laboratories, Inc. | 2 | 1997-08-25 |
| Investigacion Farmaceutica S.A. DE C.V. | 1 | 1989-08-15 |
| Oxoid U.S.A., Inc. | 1 | 1982-09-21 |
| Volu Sol Medical Industries | 1 | 1979-09-24 |
Most recent GSO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972396 | Lee Laboratories, Inc. | VISTA ANTIGEN BRUCELLA MELITENSIS | 1997-08-25 | 60 |
| K972394 | Lee Laboratories, Inc. | VISTA ANTIGEN BRUCELLA ABORTUS | 1997-08-25 | 60 |
| K952139 | Sa Scientific, Inc. | SAS BRUCELLA SUIS ANTIGEN | 1995-07-18 | 71 |
| K952136 | Sa Scientific, Inc. | SAS SALMONELLA H B ANTIGEN | 1995-07-17 | 70 |
| K952147 | Sa Scientific, Inc. | SAS BRUCELLA ABORTUS ANTIGEN | 1995-07-17 | 70 |
Recalls for GSO 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 GSO?
GSO is the FDA product code for antigens (febrile), agglutination, brucella spp.. It is a Class II device, regulated under 21 CFR 866.3085 and reviewed by the Microbiology panel.
What device class is GSO?
Class II, regulation 21 CFR 866.3085. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSO?
Across 12 cleared submissions the average was 77 days from receipt to decision (median 70).
Which companies have the most GSO clearances?
Sa Scientific, Inc. (7); Lee Laboratories, Inc. (2); Investigacion Farmaceutica S.A. DE C.V. (1); Oxoid U.S.A., Inc. (1); Volu Sol Medical Industries (1).
Have GSO 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 GSO
- Run a recall and safety report across every GSO manufacturer
- Watch product code GSO 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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