Cleared Traditional

LUTEINIZING HORMONE (LH-IRMA) RIA KIT

K864144 · Immuchem Corp. · Chemistry
Nov 1986
Decision
33d
Days
Class 1
Risk

About This 510(k) Submission

K864144 is an FDA 510(k) clearance for the LUTEINIZING HORMONE (LH-IRMA) RIA KIT, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on November 24, 1986, 33 days after receiving the submission on October 22, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K864144 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1986
Decision Date November 24, 1986
Days to Decision 33 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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