ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS— 510(k) K973054

Name: FDA 510(k) clearance K973054
Creator: U.S. Food and Drug Administration
Published: 1997-10-01

Substantially Equivalent

Emd Chemicals, Inc.

FDA 510(k) clearance K973054 for ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS, Substantially Equivalent on 1997-10-01. Applicant: Emd Chemicals, Inc.. Device class: 2.

Clearance details

Applicant: Emd Chemicals, Inc.
Product code: Code DNN
Device class: Class 2
Regulation: 21 CFR 862.3200
Advisory panel: Clinical Toxicology
Date received: 1997-08-15
Decision date: 1997-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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