Name: Predicase
Price: 199 USD

K-number	K021162
Device name	AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
Applicant	Sigma Diagnostics, Inc.
Product code	JPA
Device class	Class II
Decision date	Aug 30, 2002
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED

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