EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604— 510(k) K872513

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K872513 for EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604, Substantially Equivalent on 1987-08-21. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIG
Advisory panel: Clinical Chemistry
Date received: 1987-06-24
Decision date: 1987-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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