Cleared Traditional

ANDROSTENEDIONE 125I KIT BY RIA

K860559 · Immuchem Corp. · Chemistry
Mar 1986
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K860559 is an FDA 510(k) clearance for the ANDROSTENEDIONE 125I KIT BY RIA, a Radioimmunoassay, Androstenedione (Class I — General Controls, product code CIZ), submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on March 14, 1986, 28 days after receiving the submission on February 14, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1075.

Submission Details

510(k) Number K860559 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 1986
Decision Date March 14, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIZ — Radioimmunoassay, Androstenedione
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1075

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