EMDS(TM) ALCOHOL TESTPACKS, #67691/95— 510(k) K863419

Name: FDA 510(k) clearance K863419
Creator: U.S. Food and Drug Administration
Published: 1986-09-29

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K863419 for EMDS(TM) ALCOHOL TESTPACKS, #67691/95, Substantially Equivalent on 1986-09-29. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DML
Device class: Class 2
Regulation: 21 CFR 862.3040
Advisory panel: Clinical Toxicology
Date received: 1986-09-03
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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