Cleared Traditional

PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS

K853866 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Oct 1985
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K853866 is an FDA 510(k) clearance for the PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS, a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on October 15, 1985, 28 days after receiving the submission on September 17, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number K853866 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 1985
Decision Date October 15, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHP — Radioimmunoassay, Estradiol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1260

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