FDA product code GSM: Antisera, Fluorescent, Brucella Spp.
GSM is the FDA product code for antisera, fluorescent, brucella spp.. It is a Class II device, regulated under 21 CFR 866.3085 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under GSM. The average 510(k) review took 74 days (median 74). FDA has posted 4 recalls for GSM devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, 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 GSM clearance
Top GSM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sa Scientific, Inc. | 4 | 1995-07-21 |
Most recent GSM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952143 | Sa Scientific, Inc. | SAS BRUCELLA MELITENSIS ANTISERUM | 1995-07-21 | 74 |
| K952132 | Sa Scientific, Inc. | SAS BRUCELLA AMS ANTISERUM | 1995-07-21 | 74 |
| K952146 | Sa Scientific, Inc. | SAS BRUCELLAS ABORTUS ANTISERUM | 1995-07-21 | 74 |
| K952144 | Sa Scientific, Inc. | SAS BRUCELLA SUIS ANTISERUM | 1995-07-21 | 74 |
Recalls for GSM devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-27.
Frequently asked questions
What is FDA product code GSM?
GSM is the FDA product code for antisera, fluorescent, brucella spp.. It is a Class II device, regulated under 21 CFR 866.3085 and reviewed by the Microbiology panel.
What device class is GSM?
Class II, regulation 21 CFR 866.3085. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GSM?
Across 4 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most GSM clearances?
Sa Scientific, Inc. (4).
Have GSM devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2008-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code GSM
- Run a recall and safety report across every GSM manufacturer
- Watch product code GSM 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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