K-number	K981254
Device name	SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
Applicant	Sigma Diagnostics, Inc.
Product code	GGN
Device class	Class II
Decision date	Apr 29, 1998
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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SIGMA DIAGNOSTICS ACCUCLOT CONTROL II

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