N/T PROTEIN CONTROL UY

Multi-analyte Controls, All Kinds (assayed)

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Protein Control Uy.

Pre-market Notification Details

Device IDK914890
510k NumberK914890
Device Name:N/T PROTEIN CONTROL UY
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJohn E Hughes
CorrespondentJohn E Hughes
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-31
Decision Date1992-02-06

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