CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE— 510(k) K885272

Name: FDA 510(k) clearance K885272
Creator: U.S. Food and Drug Administration
Published: 1989-03-28

Substantially Equivalent

Sigma Chemical Co.

FDA 510(k) clearance K885272 for CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE, Substantially Equivalent on 1989-03-28. Applicant: Sigma Chemical Co.. Device class: 1.

Clearance details

Applicant: Sigma Chemical Co.
Product code: Code DIH
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1988-12-22
Decision date: 1989-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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