510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911801Substantially Equivalent

Ketosite(tm)/stat-Site(tm)/ketosite(tm) Low-Hi Con

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

K911801 is the FDA 510(k) clearance record for KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON, a class I device, cleared for Gds Technology, LLC on under FDA product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)). FDA records list 8 510(k) clearances for Gds Technology, LLC, from to . As of , FDA records show no recalls naming K911801.

Clearance record

Decision date
Received
(69 days to decision)
Product code
JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation
21 CFR 862.1435
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Gds Technology, LLC 25235 Leer Dr., Elkhart IN
510(k) summary
Statement
Third party review
No

Clearances, product code JIN

Trailing 12 months

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

FDA records show no clearances under product code JIN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIN, 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