K-number	K891370
Device name	EDL ONE-STAGE PROTHROMBIN TIME REAGENT
Applicant	Elite Diagnostic , Ltd.
Product code	GJS
Device class	Class II
Decision date	Apr 21, 1989
Decision	Substantially Equivalent
Regulation	864.7750

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View the full FDA submission: accessdata.fda.gov

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EDL ONE-STAGE PROTHROMBIN TIME REAGENT

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