The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista C1 In; Flex Reagent Cartridge, Cal, Con.
| Device ID | K072965 |
| 510k Number | K072965 |
| Device Name: | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | DBA |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-22 |
| Decision Date | 2007-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006401 | K072965 | 000 |
| 00842768006302 | K072965 | 000 |
| 00842768006418 | K072965 | 000 |