FDA Product Code JIR: Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Leading manufacturers include Boehringer Mannheim Corp., Healthy.Io, Ltd. and Helena Laboratories.
38
Total
38
Cleared
146d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Indicator Method, Protein Or Albumin (urinary, Non-quant.) Devices (Product Code JIR)
38 devices
Cleared
Sep 08, 2023
Minuteful-kidney test
Healthy.Io, Ltd.
Chemistry
347d
Cleared
Jul 06, 2022
Minuteful - kidney test
Healthy.Io, Ltd.
Chemistry
541d
Cleared
Jan 28, 1999
UALB
Abbott Laboratories
Chemistry
94d
Cleared
Oct 26, 1995
CHEMSTRIP MICRAL URINE TEST STRIPS
Boehringer Mannheim Corp.
Chemistry
38d
Cleared
Feb 10, 1995
TINA-QUANT MICROALBUMIN
Boehringer Mannheim Corp.
Chemistry
603d
Cleared
Apr 12, 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
Boehringer Mannheim Corp.
Chemistry
175d
Cleared
Apr 07, 1986
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
Diagnostic Products Corp.
Chemistry
369d
Cleared
Apr 28, 1983
HELENA BIOSTRIP P
Helena Laboratories
Chemistry
30d
About Product Code JIR - Regulatory Context
510(k) Submission Activity
38 total 510(k) submissions under product code JIR since 1981, with 38 receiving FDA clearance (average review time: 146 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.