EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95— 510(k) K864553

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K864553 for EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95, Substantially Equivalent on 1987-01-08. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code KLT
Advisory panel: Clinical Toxicology
Date received: 1986-11-19
Decision date: 1987-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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