Cleared Traditional

K791651 - TOTAL ESTROGENS KIT BY RIA
(FDA 510(k) Clearance)

K791651 · Radioassay Systems Laboratories, Inc. · Chemistry
Sep 1979
Decision
37d
Days
Class 1
Risk

K791651 is an FDA 510(k) clearance for the TOTAL ESTROGENS KIT BY RIA. This device is classified as a Radioimmunoassay, Total Estrogens, Nonpregnancy (Class I — General Controls, product code JMD).

Submitted by Radioassay Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1979, 37 days after receiving the submission on August 21, 1979.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1275.

Submission Details

510(k) Number K791651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date September 27, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JMD — Radioimmunoassay, Total Estrogens, Nonpregnancy
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1275