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 Miles Laboratories, Inc..

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 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 Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
K063276
Bayer Healthcare, LLC
Chemistry · 59d
Cleared Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Mar 21, 2002
URS-IG (GLUCOSE TEST)
K020175
Teco Diagnostics
Chemistry · 63d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Apr 08, 1997
CLINISTRIP
K970250
Teco Diagnostics
Chemistry · 76d
Cleared Mar 24, 1995
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648
Teco Diagnostics
Chemistry · 294d
Cleared Sep 09, 1994
URINE REAGENT STRIP-3 PARAMETERS
K940469
Teco Diagnostics
Chemistry · 219d
Cleared Jan 11, 1990
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Mar 06, 1987
MAJOR QUALITY GLUCOSE AND KETONES URINE TEST
K870500
American Diagnostic Corp.
Chemistry · 30d
Cleared Oct 03, 1986
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255
Behring Diagnostics, Inc.
Chemistry · 183d
Cleared Jun 13, 1986
BIOTEL (TM)/ DIABETES
K855239
American Diagnostic Corp.
Chemistry · 164d
Cleared Dec 18, 1984
UROPAPER EIKEN GP
K843753
Syn-Kit, Inc.
Chemistry · 84d
Cleared Dec 18, 1984
UROPAPER EIKEN 7
K843754
Syn-Kit, Inc.
Chemistry · 84d

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.