Name: Predicase
Price: 199 USD

K-number	K043007
Device name	BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
Applicant	Hyphen Biomed
Product code	JBQ
Device class	Class II
Decision date	Nov 7, 2005
Decision	Substantially Equivalent
Regulation	864.7060

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Source

View the full FDA submission: accessdata.fda.gov

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BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

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