JIN · Class I · 21 CFR 862.1435

FDA Product Code JIN: Nitroprusside, Ketones (urinary, Non-quant.)

Leading manufacturers include Ihara Medics U.S., Inc., Polymer Technology Intl. and I-Sens, Inc..

24
Total
24
Cleared
135d
Avg days
1980
Since

FDA 510(k) Cleared Nitroprusside, Ketones (urinary, Non-quant.) Devices (Product Code JIN)

24 devices
1–24 of 24
Cleared Sep 09, 2020
KetoSens BT Blood B-Ketone Monitoring System
K201551
I-Sens, Inc.
Chemistry · 92d
Cleared Jun 05, 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 228d
Cleared Dec 18, 2018
KET-1 Blood Ketone Monitoring System
K182593
Apex BioTechnology Corp.
Chemistry · 89d
Cleared May 04, 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345
Taidoc Technology Corporation
Chemistry · 192d
Cleared Apr 13, 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
K170463
I-Sens, Inc.
Chemistry · 422d
Cleared Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
K170587
ACON Laboratories, Inc.
Chemistry · 128d
Cleared Apr 21, 2006
PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS
K060768
Abbott Diabetes Care, Inc.
Chemistry · 30d
Cleared Apr 26, 2004
KETOCHECKS
K033114
Neo Diagnostics, Inc.
Chemistry · 209d
Cleared Apr 26, 2001
URS-1K (KETONE TESST)
K003987
Teco Diagnostics
Chemistry · 121d
Cleared Jun 14, 1996
FIRST CHOICE KETONES URINE TEST STRIPS
K953662
Polymer Technology Intl.
Chemistry · 312d
Cleared Jun 12, 1996
FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS
K953680
Polymer Technology Intl.
Chemistry · 310d
Cleared Jul 01, 1991
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
K911801
Gds Technology, LLC
Chemistry · 69d
Cleared Jul 01, 1991
KETO-340 II
K912373
Ihara Medics U.S., Inc.
Chemistry · 33d
Cleared Mar 04, 1991
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
K910108
Gds Diagnostics
Chemistry · 53d
Cleared Dec 20, 1990
KETOREX SANWA STANDARDS
K903365
Ihara Medics U.S., Inc.
Chemistry · 147d
Cleared Nov 20, 1990
KETONE TEST B SANWA STANDARD
K903366
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared Nov 20, 1990
KETONE TEST A SANWA STANDARD
K903367
Ihara Medics U.S., Inc.
Chemistry · 117d
Cleared May 27, 1988
ABBOTT BREATH ACETONE ANALYZER
K875029
Abbott Laboratories
Chemistry · 172d
Cleared Aug 30, 1985
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K850368
Sigma Chemical Co.
Chemistry · 211d
Cleared May 31, 1984
KYOTEST UK URINE TEST REAGENT STRIP
K841715
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared Jun 17, 1983
GLUCOSE 3, INLAB REAGENT STRIPS-URINALY
K831499
Laprol Scientific, Inc.
Chemistry · 37d
Cleared May 04, 1983
PLAN A LIFE
K830975
New Directions Co.
Chemistry · 40d
Cleared May 04, 1983
HELENA BIOSTRIP K
K830976
Helena Laboratories
Chemistry · 36d
Cleared Jul 08, 1980
TEST FOR KETONE IN URINE(ACETOACETIC AC
K801270
Miles Laboratories, Inc.
Chemistry · 41d

About Product Code JIN - Regulatory Context