TEST THROMBIN

Test, Thrombin Time

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK930157
510k NumberK930157
Device Name:TEST THROMBIN
ClassificationTest, Thrombin Time
Applicant BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
ContactJoseph Kiceina
CorrespondentJoseph Kiceina
BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville,  NJ  08876
Product CodeGJA  
CFR Regulation Number864.7875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-13
Decision Date1993-05-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768012716 K930157 000
00630414639635 K930157 000

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