510(k) K894262
K894262 is an FDA 510(k) premarket notification submitted by Microbix Biosystems, Inc. for the device "RUBELLA ANTIGEN AND CONTROL ANTIGEN". The FDA issued a decision of Substantially Equivalent on October 16, 1989. The device falls under product code GON (Antigen, Cf (Including Cf Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Microbix Biosystems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1989
- Date Received
- June 21, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf (Including Cf Control), Rubella
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type