GSZ — Antigens, Febrile (Weil-Felix), All Groups Class I
FDA product code GSZ covers "Antigens, Febrile (Weil-Felix), All Groups", a Class I medical device regulated under 21 CFR 866.3410. 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
- GSZ
- Device Class
- Class I
- Regulation Number
- 866.3410
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K885110 | investigacion farmaceutica s.a. de c.v | PROTEUS OX-19 IFA* | August 15, 1989 |
| K760881 | bd becton dickinson vacutainer systems preanalytic | FEBRILE ANTIGEN CONTROL SERA | November 9, 1976 |
| K760097 | gamma biologicals | FEBRILE ANTIGENS & CONTROL SERUMS | August 3, 1976 |