510(k) K890564
K890564 is an FDA 510(k) premarket notification submitted by Atlantic Antibodies for the device "SPQ(TM) ANTIBODY REAGENT SET II FOR C4". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Atlantic Antibodies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- January 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Complement C4, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5240
- Review Panel
- IM
- Submission Type