510(k) K983356
K983356 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "C4". The FDA issued a decision of Substantially Equivalent on November 4, 1998. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1998
- Date Received
- September 24, 1998
- 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