Name: Predicase
Price: 199 USD

K-number	K964609
Device name	ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
Applicant	Array Medical, Inc.
Product code	JBP
Device class	Class II
Decision date	Mar 6, 1997
Decision	Substantially Equivalent
Regulation	864.7140

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Source

View the full FDA submission: accessdata.fda.gov

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ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE

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