Cleared Traditional

17B ESTRADIOL

K810204 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Mar 1981
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K810204 is an FDA 510(k) clearance for the 17B ESTRADIOL, a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Pantex, Div. Bio-Analysis, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1981, 60 days after receiving the submission on January 26, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.

Submission Details

510(k) Number K810204 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1981
Decision Date March 27, 1981
Days to Decision 60 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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