MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS— 510(k) K133344

Substantially Equivalent

Sebia

FDA 510(k) clearance K133344 for MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS, Substantially Equivalent on 2014-03-28. Applicant: Sebia.

Clearance details

Applicant: Sebia
Product code: Code LCP
Advisory panel: Hematology
Date received: 2013-10-30
Decision date: 2014-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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