FREND PSA PLUS (REAGENT CARTRIDGE)— 510(k) K124056

Substantially Equivalent

Nanoentek, Inc.

FDA 510(k) clearance K124056 for FREND PSA PLUS (REAGENT CARTRIDGE), Substantially Equivalent on 2013-05-29. Applicant: Nanoentek, Inc..

Clearance details

Applicant: Nanoentek, Inc.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 2012-12-31
Decision date: 2013-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, CT, US

Download summary PDF View on FDA.gov ↗

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