IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R— 510(k) K930166

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K930166 for IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R, Substantially Equivalent on 1993-04-21. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JIY
Advisory panel: Clinical Chemistry
Date received: 1993-01-13
Decision date: 1993-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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