Name: Predicase
Price: 199 USD

K-number	K090413
Device name	A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
Applicant	Bayer Healthcare, LLC
Product code	LCP
Device class	Class II
Decision date	May 14, 2009
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

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