125I-TESTOSTERONE TEST SET— 510(k) K802728

Substantially Equivalent

Wien Laboratories, Inc.

FDA 510(k) clearance K802728 for 125I-TESTOSTERONE TEST SET, Substantially Equivalent on 1980-12-11. Applicant: Wien Laboratories, Inc..

Clearance details

Applicant
Wien Laboratories, Inc.
Product code
Code CDZ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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