FDA Product Code JIO: Blood, Occult, Colorimetric, In Urine
Leading manufacturers include Teco Diagnostics, ACON Laboratories, Inc. and Healgen Scientific, LLC.
11
Total
11
Cleared
189d
Avg days
1989
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Blood, Occult, Colorimetric, In Urine Devices (Product Code JIO)
11 devices
Cleared
Apr 26, 2024
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
Urit Medical Electronic Co., Ltd.
Chemistry
267d
Cleared
Apr 17, 2012
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
Healgen Scientific, LLC
Chemistry
279d
Cleared
Jan 18, 2012
MISSION U500 URINE ANALYZER
ACON Laboratories, Inc.
Chemistry
261d
Cleared
Mar 06, 2003
URS-1B (BLOOD TEST)
Teco Diagnostics
Chemistry
155d
Cleared
Sep 16, 1991
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
Remel Co.
Hematology
70d
Cleared
Feb 11, 1991
HEMASTIX REAGENT STRIPS
Heraeus Kulzer, Inc.
Chemistry
73d
About Product Code JIO - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code JIO since 1989, with 11 receiving FDA clearance (average review time: 189 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.