Cleared Traditional

K974551 - SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
(FDA 510(k) Clearance)

K974551 · Sealite Sciences, Inc. · Chemistry

Dec 1997

Decision

18d

Days

Class 2

Risk

K974551 is an FDA 510(k) clearance for the SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC).

Submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on December 22, 1997, 18 days after receiving the submission on December 4, 1997.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K974551 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 1997
Decision Date	December 22, 1997
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF