GMS — Anti-Human Globulin, Fta-Abs Test Class II
FDA product code GMS covers "Anti-Human Globulin, Fta-Abs Test", a Class II medical device regulated under 21 CFR 866.3830. 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
- GMS
- Device Class
- Class II
- Regulation Number
- 866.3830
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K853122 | immuno-products industries | IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED | September 19, 1985 |
| K843613 | immuno-products industries | FLUORESCENT TREPONEMEL ANTIBODY-ABSORB | October 31, 1984 |
| K781403 | zeus scientific | FTA-ABS TEST SYSTEM | August 21, 1978 |