UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN— 510(k) K853102

Name: FDA 510(k) clearance K853102
Creator: U.S. Food and Drug Administration
Published: 1985-08-02

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K853102 for UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN, Substantially Equivalent on 1985-08-02. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1985-07-23
Decision date: 1985-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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