K-number	K003329
Device name	SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
Applicant	Sigma Diagnostics, Inc.
Product code	GGC
Device class	Class II
Decision date	Mar 1, 2001
Decision	Substantially Equivalent
Regulation	864.5425

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SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

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