ARKIT HBA1C— 510(k) K030553

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K030553 for ARKIT HBA1C, Substantially Equivalent on 2003-09-02. Applicant: Arkray, Inc.. Device class: 2.

Clearance details

Applicant: Arkray, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2003-02-21
Decision date: 2003-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, NC, 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.