GLUCOSE-6-PHOSPHATE DEHYDROGENASE— 510(k) K823900

Name: FDA 510(k) clearance K823900
Creator: U.S. Food and Drug Administration
Published: 1983-02-07

Substantially Equivalent

Alladin Diagnostic, Inc.

FDA 510(k) clearance K823900 for GLUCOSE-6-PHOSPHATE DEHYDROGENASE, Substantially Equivalent on 1983-02-07. Applicant: Alladin Diagnostic, Inc.. Device class: 2.

Clearance details

Applicant: Alladin Diagnostic, Inc.
Product code: Code KQE
Device class: Class 2
Regulation: 21 CFR 864.7360
Advisory panel: Hematology
Date received: 1982-12-30
Decision date: 1983-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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