TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60— 510(k) K961281

Name: FDA 510(k) clearance K961281
Creator: U.S. Food and Drug Administration
Published: 1996-08-16

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K961281 for TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60, Substantially Equivalent on 1996-08-16. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1996-04-03
Decision date: 1996-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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