NA ALPHA 1 MICROGLOBULIN KIT

System, Test, Beta-2-microglobulin Immunological

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Na Alpha 1 Microglobulin Kit.

Pre-market Notification Details

Device IDK904254
510k NumberK904254
Device Name:NA ALPHA 1 MICROGLOBULIN KIT
ClassificationSystem, Test, Beta-2-microglobulin Immunological
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJohn Hughes
CorrespondentJohn Hughes
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeJZG  
CFR Regulation Number866.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-14
Decision Date1991-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768012938 K904254 000

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