Cleared Traditional

MR1 FOLLITROPIN RIA KIT

K820740 · Microanalytic Research, Inc. · Chemistry
Apr 1982
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K820740 is an FDA 510(k) clearance for the MR1 FOLLITROPIN RIA KIT, a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1982, 19 days after receiving the submission on March 18, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.

Submission Details

510(k) Number K820740 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1982
Decision Date April 06, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGJ — Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1300

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