GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET— 510(k) K860572

Name: FDA 510(k) clearance K860572
Creator: U.S. Food and Drug Administration
Published: 1986-05-16

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K860572 for GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET, Substantially Equivalent on 1986-05-16. 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: 1986-02-14
Decision date: 1986-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, 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.