Cleared Traditional

ACS LH2 IMMUNOASSAY

K962041 · Ciba Corning Diagnostics Corp. · Chemistry
Jun 1996
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K962041 is an FDA 510(k) clearance for the ACS LH2 IMMUNOASSAY, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Ciba Corning Diagnostics Corp. (Irvine, US). The FDA issued a Cleared decision on June 21, 1996, 24 days after receiving the submission on May 28, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K962041 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1996
Decision Date June 21, 1996
Days to Decision 24 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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