EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95— 510(k) K864041

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K864041 for EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95, Substantially Equivalent on 1986-11-25. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code KLS
Advisory panel: Clinical Toxicology
Date received: 1986-10-16
Decision date: 1986-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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