510(k) K852932
K852932 is an FDA 510(k) premarket notification submitted by Microbix Biosystems, Inc. for the device "MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code GRF (Antiserum, Cf, Rubeola), a Class I device regulated under 21 CFR 866.3520. Microbix Biosystems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1985
- Date Received
- July 9, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Cf, Rubeola
- Device Class
- Class I
- Regulation Number
- 866.3520
- Review Panel
- MI
- Submission Type