510(k) K994293
K994293 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION C4 FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 1, 2000. The device falls under product code DBI (Complement C4, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2000
- Date Received
- December 21, 1999
- 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