The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Ctni Flex Reagent Cartridge.
| Device ID | K063756 |
| 510k Number | K063756 |
| Device Name: | DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | George M Plummer |
| Correspondent | George M Plummer DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015151 | K063756 | 000 |