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 |