N RHEUMATOLOGY STANDARD SL

Calibrator, Multi-analyte Mixture

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Rheumatology Standard Sl.

Pre-market Notification Details

Device IDK964527
510k NumberK964527
Device Name:N RHEUMATOLOGY STANDARD SL
ClassificationCalibrator, Multi-analyte Mixture
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactRuth Forstadt
CorrespondentRuth Forstadt
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-12
Decision Date1997-01-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768007798 K964527 000
00630414287409 K964527 000

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