THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS

Differential Rate Kinetic Method, Cpk Or Isoenzymes

DADE BEHRING, INC.

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

Pre-market Notification Details

Device IDK062128
510k NumberK062128
Device Name:THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS
ClassificationDifferential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark,  DE  19714 -6101
ContactLorraine H Piestrak
CorrespondentLorraine H Piestrak
DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark,  DE  19714 -6101
Product CodeJHS  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDJG
Subsequent Product CodeDJR
Subsequent Product CodeDKZ
Subsequent Product CodeJXM
Subsequent Product CodeLCM
Subsequent Product CodeLCP
Subsequent Product CodeLDJ
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-26
Decision Date2006-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768015557 K062128 000
00842768015441 K062128 000
00842768015380 K062128 000
00842768015359 K062128 000
00842768015304 K062128 000
00842768015120 K062128 000
00842768015083 K062128 000
00842768015076 K062128 000
00842768015052 K062128 000

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