EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645— 510(k) K873426

Name: FDA 510(k) clearance K873426
Creator: U.S. Food and Drug Administration
Published: 1987-10-29

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K873426 for EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645, Substantially Equivalent on 1987-10-29. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code KLP
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1987-08-25
Decision date: 1987-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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