A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC— 510(k) K090413
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K090413 for A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC, Substantially Equivalent on 2009-05-14. Applicant: Bayer Healthcare, LLC.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code LCP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.