Cleared Traditional

IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2

K003597 · Diagnostic Products Corp. · Toxicology
Feb 2001
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K003597 is an FDA 510(k) clearance for the IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 5, 2001, 76 days after receiving the submission on November 21, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K003597 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2000
Decision Date February 05, 2001
Days to Decision 76 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LPS — Urinary Homocystine (nonquantitative) Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1377

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