IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE— 510(k) K914171

Name: FDA 510(k) clearance K914171
Creator: U.S. Food and Drug Administration
Published: 1991-12-18

Substantially Equivalent

Tech Intl. Co.

FDA 510(k) clearance K914171 for IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE, Substantially Equivalent on 1991-12-18. Applicant: Tech Intl. Co.. Device class: 1.

Clearance details

Applicant: Tech Intl. Co.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1991-09-17
Decision date: 1991-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester Hills, MI, US

Download summary PDF View on FDA.gov ↗

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