Cleared Traditional

IMMULITE HLH

K920411 · Cirrus Diagnostics, Inc. · Chemistry
Mar 1992
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K920411 is an FDA 510(k) clearance for the IMMULITE HLH, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Cirrus Diagnostics, Inc. (Chester, US). The FDA issued a Cleared decision on March 11, 1992, 40 days after receiving the submission on January 31, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K920411 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1992
Decision Date March 11, 1992
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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