JIL · Class II · 21 CFR 862.1340

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

Leading manufacturers include Miles Laboratories, Inc., Roche Diagnostics Corp. 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 Oct 08, 2003
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K032437
Roche Diagnostics Corp.
Chemistry · 62d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Jan 11, 1990
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Oct 03, 1986
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
K861255
Behring Diagnostics, Inc.
Chemistry · 183d
Cleared Sep 08, 1983
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600
Miles Laboratories, Inc.
Chemistry · 113d
Cleared May 05, 1982
BIOSTRIP G
K820594
Helena Laboratories
Chemistry · 62d
Cleared Oct 25, 1977
9-WAY URINE TEST WITH ASCORBIC
K771755
Miles Laboratories, Inc.
Chemistry · 39d
Cleared Mar 21, 1977
MEGA-DIASTIX
K761310
Miles Laboratories, Inc.
Chemistry · 88d
Cleared Mar 16, 1977
CHEMSTRIP G
K770271
Boehringer Mannheim Corp.
Chemistry · 30d

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.