FEBRILE ANTIGENS & CONTROL SERUMS
FDA 510(k) clearance K760097 · decided 1976-08-03
Clearance details
- K-number
- K760097
- Device name
- FEBRILE ANTIGENS & CONTROL SERUMS
- Applicant
- Gamma Biologicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-14
- Decision date
- 1976-08-03
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- GSZ
- Device class
- 1
- Regulation number
- 866.3410
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROTEUS OX-19 IFA* (K885110) | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 |
| FEBRILE ANTIGEN CONTROL SERA (K760881) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-11-09 |
Recalls involving this device
No recalls on record reference this clearance.