EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95— 510(k) K864925

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K864925 for EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95, Substantially Equivalent on 1987-01-07. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DIP
Advisory panel: Clinical Toxicology
Date received: 1986-12-16
Decision date: 1987-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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