EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649— 510(k) K873349

Name: FDA 510(k) clearance K873349
Creator: U.S. Food and Drug Administration
Published: 1987-09-22

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K873349 for EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649, Substantially Equivalent on 1987-09-22. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code LAN
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1987-08-20
Decision date: 1987-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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