AMMONIA ASSAY CAT. NO. 200-02— 510(k) K932556

Name: FDA 510(k) clearance K932556
Creator: U.S. Food and Drug Administration
Published: 1994-08-02

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K932556 for AMMONIA ASSAY CAT. NO. 200-02, Substantially Equivalent on 1994-08-02. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 1993-05-26
Decision date: 1994-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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K925877 — DC-UIBC-CAL1993-03-18

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