CHOLINESTERASE TEST KIT— 510(k) K912148

Name: FDA 510(k) clearance K912148
Creator: U.S. Food and Drug Administration
Published: 1991-08-12

Substantially Equivalent

Crestat Diagnostics, Inc.

FDA 510(k) clearance K912148 for CHOLINESTERASE TEST KIT, Substantially Equivalent on 1991-08-12. Applicant: Crestat Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Crestat Diagnostics, Inc.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1991-05-15
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

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