Cleared Traditional

PROGESTERONE RADIOIMMUNOASSAY KIT

K931228 · Immunotech Corp. · Chemistry
Oct 1993
Decision
226d
Days
Class 1
Risk

About This 510(k) Submission

K931228 is an FDA 510(k) clearance for the PROGESTERONE RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Immunotech Corp. (Cedex 9 (France), FR). The FDA issued a Cleared decision on October 22, 1993, 226 days after receiving the submission on March 10, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K931228 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1993
Decision Date October 22, 1993
Days to Decision 226 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLS — Radioimmunoassay, Progesterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1620

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