Cleared Traditional

DS30 HCY HOMOCYSTEINE ASSAY KIT

K982003 · Drew Scientific , Ltd. · Hematology
Feb 1999
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K982003 is an FDA 510(k) clearance for the DS30 HCY HOMOCYSTEINE ASSAY KIT, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Drew Scientific , Ltd. (Barrow In Furness, GB). The FDA issued a Cleared decision on February 11, 1999, 248 days after receiving the submission on June 8, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1377.

Submission Details

510(k) Number K982003 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1998
Decision Date February 11, 1999
Days to Decision 248 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

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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