Cleared Traditional

OPUS HLH

K962866 · Behring Diagnostics, Inc. · Chemistry
Aug 1996
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K962866 is an FDA 510(k) clearance for the OPUS HLH, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on August 23, 1996, 31 days after receiving the submission on July 23, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K962866 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1996
Decision Date August 23, 1996
Days to Decision 31 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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