RAICHEM CHOLINESTERASE REAGENT— 510(k) K862168

Name: FDA 510(k) clearance K862168
Creator: U.S. Food and Drug Administration
Published: 1986-06-27

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K862168 for RAICHEM CHOLINESTERASE REAGENT, Substantially Equivalent on 1986-06-27. Applicant: Reagents Applications, Inc.. Device class: 1.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1986-06-09
Decision date: 1986-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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