ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03— 510(k) K955633

Name: FDA 510(k) clearance K955633
Creator: U.S. Food and Drug Administration
Published: 1996-05-24

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K955633 for ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03, Substantially Equivalent on 1996-05-24. Applicant: Diagnostic Chemicals , Ltd.. Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1995-12-11
Decision date: 1996-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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