Cleared Traditional

MR1 LUTROPIN RIA KIT

K820741 · Microanalytic Research, Inc. · Chemistry
Apr 1982
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K820741 is an FDA 510(k) clearance for the MR1 LUTROPIN RIA KIT, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982, 27 days after receiving the submission on March 18, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K820741 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1982
Decision Date April 14, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEP — Radioimmunoassay, Luteinizing Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1485

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