Cleared Traditional

K994073 - HEMOSITE TEST SYSTEM

K994073 is an FDA 510(k) clearance for HEMOSITE TEST SYSTEM, manufactured by Gds Technology, LLC. The device is a Class 2 Hematology device with product code KHG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K994073 · Gds Technology, LLC · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
43d
Days
Class 2
Risk

K994073 is an FDA 510(k) clearance for the HEMOSITE TEST SYSTEM. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on January 14, 2000 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gds Technology, LLC devices

FDA 510(k) Submission Details - K994073

510(k) Number K994073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 113d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHG Device Classification - Class 2, Special Controls

Product Code KHG Whole Blood Hemoglobin Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KHG Whole Blood Hemoglobin Determination

All 30
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K994073.
AnemoCheck
K163215 · Sanguina, LLC · Sep 2017
ANEMIAPRO SELF-SCREENER
K042379 · Biosafe Laboratories, Inc. · Dec 2004
CARESIDE HEMOGLOBIN
K001462 · Careside, Inc. · Aug 2000
HEMOSITE TEST SYSTEM
K973649 · Gds Technology, LLC · Aug 1998
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221 · Abbott Laboratories · Sep 1995
REFLOTRON HEMOGLOBIN TEST TABS
K934064 · Boehringer Mannheim Corp. · Dec 1993