Cleared Traditional

K170232 - AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
(FDA 510(k) Clearance)

K170232 · Boditech Med, Inc. · Chemistry
Oct 2017
Decision
261d
Days
Class 2
Risk

K170232 is an FDA 510(k) clearance for the AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Boditech Med, Inc. (Chuncheon-Si, KR). The FDA issued a Cleared decision on October 13, 2017, 261 days after receiving the submission on January 25, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K170232 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2017
Decision Date October 13, 2017
Days to Decision 261 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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