EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640— 510(k) K871329

Name: FDA 510(k) clearance K871329
Creator: U.S. Food and Drug Administration
Published: 1987-05-12

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K871329 for EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640, Substantially Equivalent on 1987-05-12. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1987-04-03
Decision date: 1987-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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