BC THROMBIN REAGENT

Test, Thrombin Time

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK970645
510k NumberK970645
Device Name:BC THROMBIN REAGENT
ClassificationTest, Thrombin Time
Applicant BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
ContactPaul L Rogers, Jr.
CorrespondentPaul L Rogers, Jr.
BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
Product CodeGJA  
CFR Regulation Number864.7875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-20
Decision Date1997-05-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768013102 K970645 000

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