Cleared Traditional

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control

K160541 · Sysmex America, Inc. · Chemistry
Oct 2016
Decision
238d
Days
Class 2
Risk

About This 510(k) Submission

K160541 is an FDA 510(k) clearance for the Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on October 21, 2016, 238 days after receiving the submission on February 26, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K160541 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2016
Decision Date October 21, 2016
Days to Decision 238 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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