TESTOTERONE ELISA— 510(k) K973900

Substantially Equivalent

Kmi Diagnostics, Inc.

FDA 510(k) clearance K973900 for TESTOTERONE ELISA, Substantially Equivalent on 1998-02-24. Applicant: Kmi Diagnostics, Inc..

Clearance details

Applicant: Kmi Diagnostics, Inc.
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 1997-10-14
Decision date: 1998-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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