Name: Predicase
Price: 199 USD

K-number	K083729
Device name	HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
Applicant	Aniara Diagnostica, LLC
Product code	GGW
Device class	Class II
Decision date	May 8, 2009
Decision	Substantially Equivalent
Regulation	864.7925

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Source

View the full FDA submission: accessdata.fda.gov

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HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

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