TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED)— 510(k) K120009

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K120009 for TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED), Substantially Equivalent on 2012-09-11. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CDZ
Advisory panel: Clinical Chemistry
Date received: 2012-01-03
Decision date: 2012-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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