GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT— 510(k) K924496

Name: FDA 510(k) clearance K924496
Creator: U.S. Food and Drug Administration
Published: 1992-11-16

Substantially Equivalent

Drew Scientific , Ltd.

FDA 510(k) clearance K924496 for GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT, Substantially Equivalent on 1992-11-16. Applicant: Drew Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Drew Scientific , Ltd.
Product code: Code JPD
Device class: Class 2
Regulation: 21 CFR 864.7400
Advisory panel: Hematology
Date received: 1992-09-04
Decision date: 1992-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London W4 4ph Uk, GB

Download summary PDF View on FDA.gov ↗

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