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510(k) K911801

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON by Gds Technology, LLC — Product Code JIN

K911801 is an FDA 510(k) premarket notification submitted by Gds Technology, LLC for the device "KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON". The FDA issued a decision of Substantially Equivalent on July 1, 1991. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Gds Technology, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1991
Date Received
April 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1435
Review Panel
CH
Submission Type

Other clearances by Gds Technology, LLC

  • K020138 — STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARD (February 11, 2002)
  • K994073 — HEMOSITE TEST SYSTEM (January 14, 2000)
  • K992132 — CHOLESITE TEST SYSTEM (August 20, 1999)
  • K973649 — HEMOSITE TEST SYSTEM (August 31, 1998)
  • K971145 — GLUCOSITE TEST SYSTEM (September 17, 1997)
  • K882038 — GDS ENZYMATIC SALICYLATE REAGENT (June 24, 1988)
  • K880829 — GDS ENZYMATIC ACETAMINOPHEN REAGENT (May 27, 1988)

Other clearances for product code JIN

  • K201551 — KetoSens BT Blood B-Ketone Monitoring System (September 9, 2020)
  • K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System (June 5, 2020)
  • K182593 — KET-1 Blood Ketone Monitoring System (December 18, 2018)
  • K173345 — TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System (May 4, 2018)
  • K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitor (April 13, 2018)
  • K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips f (July 6, 2017)
  • K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (April 21, 2006)
  • K033114 — KETOCHECKS (April 26, 2004)
  • K003987 — URS-1K (KETONE TESST) (April 26, 2001)
  • K953662 — FIRST CHOICE KETONES URINE TEST STRIPS (June 14, 1996)

FDA data resources