DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID— 510(k) K080618

Name: FDA 510(k) clearance K080618
Creator: U.S. Food and Drug Administration
Published: 2008-05-23

Substantially Equivalent

Jas Diagnostics, Inc.

FDA 510(k) clearance K080618 for DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID, Substantially Equivalent on 2008-05-23. Applicant: Jas Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Jas Diagnostics, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2008-03-05
Decision date: 2008-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.