DIMENSION VISTA FLEX REAGENT CARTRIDGES

Colorimetry, Acetaminophen

DADE BEHRING, INC.

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

Pre-market Notification Details

Device IDK061655
510k NumberK061655
Device Name:DIMENSION VISTA FLEX REAGENT CARTRIDGES
ClassificationColorimetry, Acetaminophen
Applicant DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG.500 M.S. 514; PO BOX 6101 Newark,  DE  19714 -6101
ContactLorraine H Piestrak
CorrespondentLorraine H Piestrak
DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG.500 M.S. 514; PO BOX 6101 Newark,  DE  19714 -6101
Product CodeLDP  
Subsequent Product CodeCDT
Subsequent Product CodeCEO
Subsequent Product CodeCFR
Subsequent Product CodeCHH
Subsequent Product CodeDIH
Subsequent Product CodeDKJ
Subsequent Product CodeJFJ
Subsequent Product CodeJGJ
Subsequent Product CodeJHS
Subsequent Product CodeJQB
Subsequent Product CodeKLI
Subsequent Product CodeKLR
Subsequent Product CodeKNK
Subsequent Product CodeLAR
Subsequent Product CodeLBS
Subsequent Product CodeLCR
Subsequent Product CodeLEG
Subsequent Product CodeLEH
Subsequent Product CodeMRR
Subsequent Product Code&nb
CFR Regulation Number862.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-13
Decision Date2006-07-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768015663 K061655 000
00842768015229 K061655 000
00842768015267 K061655 000
00842768015373 K061655 000
00842768015489 K061655 000
00842768015519 K061655 000
00842768015700 K061655 000
00842768015014 K061655 000
00842768015069 K061655 000
00842768015281 K061655 000
00842768015403 K061655 000
00842768015427 K061655 000
00842768015434 K061655 000
00842768015472 K061655 000
00842768015526 K061655 000
00842768015533 K061655 000
00842768015090 K061655 000

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