Cleared Traditional

MICRO-ELISA HLH TEST KIT MONOCLONAL

K860333 · Bioclinical Systems, Inc. · Chemistry
Apr 1986
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K860333 is an FDA 510(k) clearance for the MICRO-ELISA HLH TEST KIT MONOCLONAL, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Bioclinical Systems, Inc. (St.Louis, US). The FDA issued a Cleared decision on April 21, 1986, 82 days after receiving the submission on January 29, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K860333 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1986
Decision Date April 21, 1986
Days to Decision 82 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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