TESTOSTERONE DIRECT RADIOIMMUNOASSAY— 510(k) K841948

Substantially Equivalent

Sorin Biomedica, Fiat, USA, Inc.

FDA 510(k) clearance K841948 for TESTOSTERONE DIRECT RADIOIMMUNOASSAY, Substantially Equivalent on 1984-06-25. Applicant: Sorin Biomedica, Fiat, USA, Inc..

Clearance details

Applicant
Sorin Biomedica, Fiat, USA, Inc.
Product code
Code CDZ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.