GSN — Antiserum, Positive And Negative Febrile Antigen Control Serum Class II
FDA product code GSN covers "Antiserum, Positive And Negative Febrile Antigen Control Serum", a Class II medical device regulated under 21 CFR 866.3085. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GSN
- Device Class
- Class II
- Regulation Number
- 866.3085
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952145 | sa scientific | SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM | July 18, 1995 |
| K885113 | investigacion farmaceutica s.a. de c.v | IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL | August 15, 1989 |
| K791385 | immuno-mycologics | NEGATIVE CONTROL SERUM FOR CF RO ID | August 16, 1979 |