SICKLE CELL REAGENT SET— 510(k) K811828

Name: FDA 510(k) clearance K811828
Creator: U.S. Food and Drug Administration
Published: 1981-08-12

Substantially Equivalent

Anco Medical Reagents & Assoc.

FDA 510(k) clearance K811828 for SICKLE CELL REAGENT SET, Substantially Equivalent on 1981-08-12. Applicant: Anco Medical Reagents & Assoc.. Device class: 2.

Clearance details

Applicant: Anco Medical Reagents & Assoc.
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1981-06-29
Decision date: 1981-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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