Cleared Traditional

FREND TSH (REAGENT CARTRIDGE)

K131928 · Nanoentek USA, Inc. · Chemistry
Mar 2014
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K131928 is an FDA 510(k) clearance for the FREND TSH (REAGENT CARTRIDGE), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Nanoentek USA, Inc. (Oxford, US). The FDA issued a Cleared decision on March 14, 2014, 260 days after receiving the submission on June 27, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K131928 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2013
Decision Date March 14, 2014
Days to Decision 260 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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