Cleared Traditional

HEMOSITE TEST SYSTEM

K994073 · Gds Technology, LLC · Hematology
Jan 2000
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K994073 is an FDA 510(k) clearance for the HEMOSITE TEST SYSTEM, a Whole Blood Hemoglobin Determination (Class II — Special Controls, product code KHG), submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on January 14, 2000, 43 days after receiving the submission on December 2, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K994073 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1999
Decision Date January 14, 2000
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KHG — Whole Blood Hemoglobin Determination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7500

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