DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN

Calibrator, Multi-analyte Mixture

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Protein 1 Calibrator And Control L, M, H; Protein 2 Calibrator And Control L, H; Protein 3 Calibrator An.

Pre-market Notification Details

Device IDK063508
510k NumberK063508
Device Name:DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
ClassificationCalibrator, Multi-analyte Mixture
Applicant DADE BEHRING, INC. P.O. BOX 6101 Newark,,  DE  19714
ContactHelen M Lee
CorrespondentHelen M Lee
DADE BEHRING, INC. P.O. BOX 6101 Newark,,  DE  19714
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-20
Decision Date2007-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768006463 K063508 000
00842768006487 K063508 000
00842768006470 K063508 000

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