Cleared Traditional

HEMOSITE TEST SYSTEM

K973649 · Gds Technology, LLC · Microbiology
Aug 1998
Decision
340d
Days
Class 2
Risk

About This 510(k) Submission

K973649 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 August 31, 1998, 340 days after receiving the submission on September 25, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number K973649 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1997
Decision Date August 31, 1998
Days to Decision 340 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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

Similar Devices — KHG Whole Blood Hemoglobin Determination

All 38
AnemoCheck Home
K221508 · Sanguina, Inc. · Sep 2023
AnemoCheck
K163215 · Sanguina, LLC · Sep 2017
ANEMIAPRO SELF-SCREENER
K042379 · Biosafe Laboratories, Inc. · Dec 2004
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
K020138 · Gds Technology · Feb 2002
CARESIDE HEMOGLOBIN
K001462 · Careside, Inc. · Aug 2000
HEMOSITE TEST SYSTEM
K994073 · Gds Technology, LLC · Jan 2000