510(k) K791388
K791388 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "ANTI-COCCIDIOIDES SERUM #CF10028X". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code GMH (Antiserum, Positive Control, Coccidioides Immitis), a Class II device regulated under 21 CFR 866.3135. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1979
- Date Received
- July 11, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Positive Control, Coccidioides Immitis
- Device Class
- Class II
- Regulation Number
- 866.3135
- Review Panel
- MI
- Submission Type