EMDS(TM) ALBUMIN TESTPACKS, #67652/95— 510(k) K863004

Name: FDA 510(k) clearance K863004
Creator: U.S. Food and Drug Administration
Published: 1986-09-16

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K863004 for EMDS(TM) ALBUMIN TESTPACKS, #67652/95, Substantially Equivalent on 1986-09-16. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CJW
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1986-08-08
Decision date: 1986-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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