Cleared Traditional

T-UPTAKE EIA TEST

K951586 · Diagnostic Reagents, Inc. · Chemistry
May 1995
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K951586 is an FDA 510(k) clearance for the T-UPTAKE EIA TEST, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 15, 1995, 39 days after receiving the submission on April 6, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K951586 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1995
Decision Date May 15, 1995
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KHQ — Radioassay, Triiodothyronine Uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1715

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