ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS— 510(k) K881344

Name: FDA 510(k) clearance K881344
Creator: U.S. Food and Drug Administration
Published: 1989-01-24

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K881344 for ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS, Substantially Equivalent on 1989-01-24. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code DIC
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1988-03-30
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

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