CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05— 510(k) K955498

Name: FDA 510(k) clearance K955498
Creator: U.S. Food and Drug Administration
Published: 1996-01-24

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K955498 for CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05, Substantially Equivalent on 1996-01-24. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1995-12-01
Decision date: 1996-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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