TURBIQUANT MYOGLOBIN

Myoglobin, Antigen, Antiserum, Control

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK903687
510k NumberK903687
Device Name:TURBIQUANT MYOGLOBIN
ClassificationMyoglobin, Antigen, Antiserum, Control
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 CodeDDR  
CFR Regulation Number866.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-15
Decision Date1990-10-16

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