HEMOGLOBIN REAGENT— 510(k) K821658

Name: FDA 510(k) clearance K821658
Creator: U.S. Food and Drug Administration
Published: 1982-06-25

Substantially Equivalent

Anco Medical Reagents & Assoc.

FDA 510(k) clearance K821658 for HEMOGLOBIN REAGENT, Substantially Equivalent on 1982-06-25. Applicant: Anco Medical Reagents & Assoc.. Device class: 2.

Clearance details

Applicant: Anco Medical Reagents & Assoc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1982-06-04
Decision date: 1982-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.