Cleared Traditional

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.

K870158 · American Dade · Chemistry
Mar 1987
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K870158 is an FDA 510(k) clearance for the STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO., a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on March 19, 1987, 65 days after receiving the submission on January 13, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K870158 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1987
Decision Date March 19, 1987
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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