Cleared Traditional

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY

K923532 · Solarcare Technologies Corp,Inc. · Chemistry
Mar 1993
Decision
239d
Days
Class 2
Risk

About This 510(k) Submission

K923532 is an FDA 510(k) clearance for the NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 12, 1993, 239 days after receiving the submission on July 16, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K923532 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1992
Decision Date March 12, 1993
Days to Decision 239 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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