EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93— 510(k) K860641

Name: FDA 510(k) clearance K860641
Creator: U.S. Food and Drug Administration
Published: 1986-04-03

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K860641 for EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93, Substantially Equivalent on 1986-04-03. Applicant: Em Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DLI
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1986-02-20
Decision date: 1986-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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