ACS ESTADIOL-6 II— 510(k) K970386

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K970386 for ACS ESTADIOL-6 II, Substantially Equivalent on 1997-06-04. Applicant: Chiron Diagnostics Corp..

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code CHP
Advisory panel: Clinical Chemistry
Date received: 1997-02-03
Decision date: 1997-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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