The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension C3 Flex Reagent Cartridge.
| Device ID | K994296 |
| 510k Number | K994296 |
| Device Name: | DIMENSION C3 FLEX REAGENT CARTRIDGE |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Richard M Vaught |
| Correspondent | Richard M Vaught DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-21 |
| Decision Date | 2000-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005220 | K994296 | 000 |