Cleared Traditional

TSH-P.E.G.

K811558 · Nuclear Diagnostics, Inc. · Chemistry
Jun 1981
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K811558 is an FDA 510(k) clearance for the TSH-P.E.G., a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Nuclear Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 18, 1981, 16 days after receiving the submission on June 2, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K811558 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1981
Decision Date June 18, 1981
Days to Decision 16 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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