CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)— 510(k) K162281

Name: FDA 510(k) clearance K162281
Creator: U.S. Food and Drug Administration
Published: 2017-02-17

Substantially Equivalent

Sebia

FDA 510(k) clearance K162281 for CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2), Substantially Equivalent on 2017-02-17. 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: 2016-08-15
Decision date: 2017-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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