Name: Predicase
Price: 199 USD

K-number	K012567
Device name	MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
Applicant	Corgenix, Inc.
Product code	MID
Device class	Class II
Decision date	Aug 23, 2001
Decision	Substantially Equivalent
Regulation	866.5660

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

Everything you need for a 510(k) submission. Nothing you don't.