Cleared Traditional

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT

K862336 · Pantex, Div. Bio-Analysis, Inc. · Chemistry
Sep 1986
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K862336 is an FDA 510(k) clearance for the PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Cortisol (Class II — Special Controls, product code CGR), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 25, 1986, 97 days after receiving the submission on June 20, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number K862336 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1986
Decision Date September 25, 1986
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGR — Radioimmunoassay, Cortisol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1205

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