Cleared Traditional

STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY

K933414 · Baxter Diagnostics, Inc. · Chemistry
Nov 1994
Decision
497d
Days
Class 2
Risk

About This 510(k) Submission

K933414 is an FDA 510(k) clearance for the STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1994, 497 days after receiving the submission on July 13, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K933414 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 1993
Decision Date November 22, 1994
Days to Decision 497 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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