LABONACHECK A1C— 510(k) K111128

Substantially Equivalent

Ceragem International, Inc.

FDA 510(k) clearance K111128 for LABONACHECK A1C, Substantially Equivalent on 2012-09-13. Applicant: Ceragem International, Inc.. Device class: 2.

Clearance details

Applicant: Ceragem International, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2011-04-21
Decision date: 2012-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.