JIL · Class II · 21 CFR 862.1340

FDA Product Code JIL: Method, Enzymatic, Glucose (urinary, Non-quantitative)

Leading manufacturers include Syn-Kit, Inc., Teco Diagnostics and DFI Co., Ltd..

81
Total
81
Cleared
152d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Method, Enzymatic, Glucose (urinary, Non-quantitative) Devices (Product Code JIL)

81 devices
1–24 of 81
Cleared Apr 13, 2023
AUTION MAX AX-4060 Urinalysis System
K193514
Arkray, Inc.
Chemistry · 1211d
Cleared May 07, 2019
cobas u 601 urinalysis test system
K183432
Roche Diagnostics
Chemistry · 147d
Cleared Jul 18, 2018
DIP/U.S. Urine Analysis Test System
K173327
Healthy.Io, Ltd.
Chemistry · 271d
Cleared May 25, 2018
inui In-Home Urine Analysis Test System
K180356
Scanadu, Inc.
Chemistry · 106d
Cleared May 23, 2018
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K181024
DFI Co., Ltd.
Chemistry · 35d
Cleared Feb 16, 2018
DUS R-50S (Urine Chemistry system)
K171521
DFI Co., Ltd.
Chemistry · 268d
Cleared May 12, 2017
iChemVELOCITY Automated Urine Chemistry System
K171083
Iris Diagnostics, A Division of Iris International, Inc.
Chemistry · 31d
Cleared Oct 07, 2016
AUTION ELEVEN Semi-Automated Urinalysis System
K160062
Arkray, Inc.
Chemistry · 269d
Cleared Jul 22, 2016
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
K160372
Teco Diagnostics, Inc.
Chemistry · 163d
Cleared Jul 24, 2015
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
K141289
Teco Diagnostics
Chemistry · 431d
Cleared May 29, 2014
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600
Teco Diagnostics
Chemistry · 360d
Cleared Mar 06, 2012
FORESIGHT U120 URINE ANALYZER
K120124
ACON Laboratories, Inc.
Chemistry · 49d
Cleared Feb 04, 2011
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673
Teco Diagnostics
Chemistry · 234d
Cleared Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216
Siemens Healthcare Diagnostics
Chemistry · 165d
Cleared Apr 06, 2007
COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005
K061812
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Apr 06, 2007
COMBI SCAN100
K061846
Analyticon Biotechnologies AG
Chemistry · 284d
Cleared Mar 01, 2007
URINE CHEMISTRY ANALYZER UR-50
K063390
Ind Diagnostic, Inc.
Chemistry · 112d
Cleared Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
K063276
Bayer Healthcare, LLC
Chemistry · 59d
Cleared Sep 06, 2006
URYXXON RELAX URINE ANALYZER
K061742
Macherey-Nagel GmbH & Co. KG
Chemistry · 78d
Cleared Jun 13, 2006
ICHEM 100 URINE CHEMISTRY ANALYZER
K060280
Iris International, Inc.
Chemistry · 131d
Cleared Mar 29, 2006
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS
K052525
DFI Co., Ltd.
Chemistry · 196d
Cleared Nov 22, 2005
URYXXON 200 URINE ANALYZER
K051034
Macherey-Nagel GmbH & Co. KG
Chemistry · 214d
Cleared Apr 20, 2005
URISCAN OPTIMA II URINE ANALYZER
K050801
Yd Diagnostics
Chemistry · 21d
Cleared Jan 07, 2005
CHEMVIEW-10
K042641
Cenogenics Corp.
Chemistry · 102d

About Product Code JIL - Regulatory Context

510(k) Submission Activity

81 total 510(k) submissions under product code JIL since 1977, with 81 receiving FDA clearance (average review time: 152 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.