510(k) K760097
K760097 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "FEBRILE ANTIGENS & CONTROL SERUMS". The FDA issued a decision of Substantially Equivalent on August 3, 1976. The device falls under product code GSZ (Antigens, Febrile (Weil-Felix), All Groups), a Class I device regulated under 21 CFR 866.3410. Gamma Biologicals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1976
- Date Received
- June 14, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, Febrile (Weil-Felix), All Groups
- Device Class
- Class I
- Regulation Number
- 866.3410
- Review Panel
- MI
- Submission Type