HEMOGLOBIN A1C REAGENT SET— 510(k) K031539

Name: FDA 510(k) clearance K031539
Creator: U.S. Food and Drug Administration
Published: 2003-08-06

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K031539 for HEMOGLOBIN A1C REAGENT SET, Substantially Equivalent on 2003-08-06. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2003-05-16
Decision date: 2003-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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