FDA Product Code LJX: Test, Urine Leukocyte
Leading manufacturers include Miles Laboratories, Inc., Dia-Screen Corp. and Chronimed, Inc..
7
Total
7
Cleared
94d
Avg days
1985
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Test, Urine Leukocyte Devices (Product Code LJX)
7 devices
Cleared
Jun 16, 2023
Healgen URS Test Strips
Healgen Scientific, LLC
Chemistry
65d
Cleared
Oct 12, 2007
ACON UTI URINARY TRACT INFECTION TEST STRIPS
ACON Laboratories, Inc.
Chemistry
345d
Cleared
May 05, 2000
SERIM LEUKOCYTE ESTERASE TEST STRIPS
Serim Research Corp.
Hematology
73d
Cleared
Jun 01, 1998
DIASCREEN REAGENT STRIPS
Chronimed, Inc.
Chemistry
31d
Cleared
Jun 17, 1997
DIASCREEN REAGENT STRIPS
Dia-Screen Corp.
Hematology
19d
Cleared
Sep 11, 1987
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
Miles Laboratories, Inc.
Hematology
24d
Cleared
Jan 04, 1985
LEUKOSTIX REAGENT STRIPS FOR URINALYSIS
Miles Laboratories, Inc.
Chemistry
102d
About Product Code LJX - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code LJX since 1985, with 7 receiving FDA clearance (average review time: 94 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.