Cleared Traditional

LH RADIOIMMUNOASSAY TEST SYSTEM

K820760 · Monobind · Chemistry
Apr 1982
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K820760 is an FDA 510(k) clearance for the LH RADIOIMMUNOASSAY TEST SYSTEM, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on April 16, 1982, 25 days after receiving the submission on March 22, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K820760 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 1982
Decision Date April 16, 1982
Days to Decision 25 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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