BEHRING NEPHELOMETER 100

Nephelometer

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Nephelometer 100.

Pre-market Notification Details

Device IDK892223
510k NumberK892223
Device Name:BEHRING NEPHELOMETER 100
ClassificationNephelometer
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJohn W Hufhwa
CorrespondentJohn W Hufhwa
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeJZW  
CFR Regulation Number866.4540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-03
Decision Date1989-05-04

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