FREND Testosterone Test System— 510(k) K153577

Substantially Equivalent

Nanoentek USA, Inc.

FDA 510(k) clearance K153577 for FREND Testosterone Test System, Substantially Equivalent on 2016-10-14. Applicant: Nanoentek USA, Inc..

Clearance details

Applicant
Nanoentek USA, Inc.
Product code
Code CDZ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
Download summary PDFView on FDA.gov ↗

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