Cleared Traditional

IDS-iSYS Intact PTHN

K161158 · Immunodiagnostic Systems , Ltd. · Chemistry
Jan 2017
Decision
281d
Days
Class 2
Risk

About This 510(k) Submission

K161158 is an FDA 510(k) clearance for the IDS-iSYS Intact PTHN, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on January 31, 2017, 281 days after receiving the submission on April 25, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K161158 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2016
Decision Date January 31, 2017
Days to Decision 281 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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