GPW — Antigen, Cf, Psittacosis (Chlamydia Group) Class I
FDA product code GPW covers "Antigen, Cf, Psittacosis (Chlamydia Group)", a Class I medical device regulated under 21 CFR 866.3120. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GPW
- Device Class
- Class I
- Regulation Number
- 866.3120
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K872700 | sita | YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN | October 15, 1987 |
| K843654 | institute virion | CHLAMYDIA | August 8, 1985 |
| K844868 | hillcrest biologicals | CHLAMYDIA GROUP CF ANTIGEN | March 5, 1985 |
| K811570 | electro-nucleonics laboratories | ANTIBODY TO CHLAMYDIA TRACHOMATIS | July 23, 1981 |