Cleared Traditional

KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON

K911801 · Gds Technology, LLC · Chemistry
Jul 1991
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K911801 is an FDA 510(k) clearance for the KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON, a Nitroprusside, Ketones (urinary, Non-quant.) (Class I — General Controls, product code JIN), submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on July 1, 1991, 69 days after receiving the submission on April 23, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1435.

Submission Details

510(k) Number K911801 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1991
Decision Date July 01, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIN — Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1435

Similar Devices — JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 23
KetoSens BT Blood B-Ketone Monitoring System
K201551 · I-Sens, Inc. · Sep 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957 · Vivachek Biotech (Hangzhou) Co., Ltd. · Jun 2020
KET-1 Blood Ketone Monitoring System
K182593 · Apex BioTechnology Corp. · Dec 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345 · Taidoc Technology Corporation · May 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
K170463 · I-Sens, Inc. · Apr 2018
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
K170587 · ACON Laboratories, Inc. · Jul 2017