DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE

Immunoassay Method, Troponin Subunit

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Ctni Flex Reagent Cartridge.

Pre-market Notification Details

Device IDK063756
510k NumberK063756
Device Name:DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
ClassificationImmunoassay Method, Troponin Subunit
Applicant DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark,  DE  19714 -6101
ContactGeorge M Plummer
CorrespondentGeorge M Plummer
DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark,  DE  19714 -6101
Product CodeMMI  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-19
Decision Date2007-03-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768015151 K063756 000

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