K-number	K000528
Device name	ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
Applicant	Sigma Diagnostics, Inc.
Product code	GIR
Device class	Class I
Decision date	Apr 7, 2000
Decision	Substantially Equivalent
Regulation	864.8950

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View the full FDA submission: accessdata.fda.gov

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ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119

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