Cleared Traditional

NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY

K925649 · Solarcare Technologies Corp,Inc. · Chemistry
Mar 1993
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K925649 is an FDA 510(k) clearance for the NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 1, 1993, 112 days after receiving the submission on November 9, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K925649 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1992
Decision Date March 01, 1993
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CEC — Radioimmunoassay, Free Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1695