K-number	K920147
Device name	THROMBIN CLOTTING TIME REAGENT
Applicant	Helena Laboratories
Product code	GJA
Device class	Class II
Decision date	May 1, 1992
Decision	Substantially Equivalent
Regulation	864.7875

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View the full FDA submission: accessdata.fda.gov

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THROMBIN CLOTTING TIME REAGENT

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