K090413

Substantially Equivalent

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
Advisory panel: Hematology
Date received: 2009-02-18
Decision date: 2009-05-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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