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

Name: FDA 510(k) clearance K124056
Creator: U.S. Food and Drug Administration
Published: 2013-05-29

Substantially Equivalent

Nanoentek, Inc.

FDA 510(k) clearance K124056 for FREND PSA PLUS (REAGENT CARTRIDGE), Substantially Equivalent on 2013-05-29. Applicant: Nanoentek, Inc.. Device class: 2.

Clearance details

Applicant: Nanoentek, Inc.
Product code: Code LTJ
Device class: Class 2
Regulation: 21 CFR 866.6010
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 ↗

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