EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93— 510(k) K870247

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K870247 for EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93, Substantially Equivalent on 1987-02-11. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DLJ
Advisory panel: Clinical Toxicology
Date received: 1987-01-21
Decision date: 1987-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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