Cleared Traditional

PROGESTERONE RADIOIMMUNOASSAY KIT

K791051 · Cis Radiopharmaceuticals, Inc. · Chemistry
Jul 1979
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K791051 is an FDA 510(k) clearance for the PROGESTERONE RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979, 48 days after receiving the submission on June 6, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.

Submission Details

510(k) Number K791051 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1979
Decision Date July 24, 1979
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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