510(k) K885112
K885112 is an FDA 510(k) premarket notification submitted by Investigacion Farmaceutica S.A. DE C.V. for the device "BRUCELLA IFA*". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code GSO (Antigens (Febrile), Agglutination, Brucella Spp.), a Class II device regulated under 21 CFR 866.3085. Investigacion Farmaceutica S.A. DE C.V. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1989
- Date Received
- December 12, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens (Febrile), Agglutination, Brucella Spp.
- Device Class
- Class II
- Regulation Number
- 866.3085
- Review Panel
- MI
- Submission Type