Name: Predicase
Price: 199 USD

K-number	K974505
Device name	AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
Applicant	Alfa Biotech (Uk) , Ltd.
Product code	DBF
Device class	Class II
Decision date	Feb 17, 1998
Decision	Substantially Equivalent
Regulation	866.5340

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Source

View the full FDA submission: accessdata.fda.gov

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AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501

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