510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973649Substantially Equivalent

Hemosite Test System

Gds Technology, LLC, Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973649 is the FDA 510(k) clearance record for HEMOSITE TEST SYSTEM, a class II device, cleared for Gds Technology, LLC on under FDA product code KHG (Whole Blood Hemoglobin Determination). FDA records list 8 510(k) clearances for Gds Technology, LLC, from to . As of , FDA records show no recalls naming K973649.

Clearance record

Decision date
Received
(340 days to decision)
Product code
KHG Whole Blood Hemoglobin Determination
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Gds Technology, LLC 25235 Leer Dr., Elkhart IN
510(k) summary
Summary
Third party review
No

Clearances, product code KHG

Trailing 12 months

FDA records hold no clearances under product code KHG in the trailing twelve months.

FDA records show no clearances under product code KHG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260