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

Name: FDA 510(k) clearance K133344
Creator: U.S. Food and Drug Administration
Published: 2014-03-28

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. Device class: 2.

Clearance details

Applicant: Sebia
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2013-10-30
Decision date: 2014-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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