Cleared Traditional

K822935 - THYROID STIMULATING HORMONE
(FDA 510(k) Clearance)

K822935 · Pcl-Ria, Inc. · Chemistry
Nov 1982
Decision
28d
Days
Class 2
Risk

K822935 is an FDA 510(k) clearance for the THYROID STIMULATING HORMONE. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW).

Submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982, 28 days after receiving the submission on October 4, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K822935 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1982
Decision Date November 01, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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