THROMBIN CLOTTING TIME REAGENT

Test, Thrombin Time

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Thrombin Clotting Time Reagent.

Pre-market Notification Details

Device IDK920147
510k NumberK920147
Device Name:THROMBIN CLOTTING TIME REAGENT
ClassificationTest, Thrombin Time
Applicant HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
ContactPat Franks
CorrespondentPat Franks
HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont,  TX  77704
Product CodeGJA  
CFR Regulation Number864.7875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-13
Decision Date1992-05-01

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