K-number	K972796
Device name	SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
Applicant	Sigma Diagnostics, Inc.
Product code	GJS
Device class	Class II
Decision date	Oct 10, 1997
Decision	Substantially Equivalent
Regulation	864.7750

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View the full FDA submission: accessdata.fda.gov

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SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM

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