K-number	K010158
Device name	THROMBOMAX-HS WITH CALCIUM, MODEL T6540
Applicant	Sigma Diagnostics, Inc.
Product code	GGO
Device class	Class II
Decision date	Mar 22, 2001
Decision	Substantially Equivalent
Regulation	864.7925

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View the full FDA submission: accessdata.fda.gov

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THROMBOMAX-HS WITH CALCIUM, MODEL T6540

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