JIR · Class I · 21 CFR 862.1645

FDA Product Code JIR: Indicator Method, Protein Or Albumin (urinary, Non-quant.)

Leading manufacturers include Bayer Corp., Boehringer Mannheim Corp. and Diagnostic Chemicals , Ltd..

38
Total
38
Cleared
146d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Indicator Method, Protein Or Albumin (urinary, Non-quant.) Devices (Product Code JIR)

38 devices
1–24 of 38
Cleared Sep 08, 2023
Minuteful-kidney test
K222921
Healthy.Io, Ltd.
Chemistry · 347d
Cleared Jul 06, 2022
Minuteful - kidney test
K210069
Healthy.Io, Ltd.
Chemistry · 541d
Cleared Apr 30, 2015
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
K150330
ACON Laboratories, Inc.
Chemistry · 79d
Cleared Jan 26, 2007
TECO MICROALBUMIN 2-1 COMBO STRIPS
K061419
Teco Diagnostics
Chemistry · 249d
Cleared Aug 23, 2002
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Feb 01, 2000
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035
Diagnostic Chemicals , Ltd.
Chemistry · 64d
Cleared Nov 24, 1999
NEW MULTIPLES REAGENT STRIPS
K992257
Bayer Corp.
Chemistry · 141d
Cleared Nov 12, 1999
MICROALBUSTIX REAGENT STRIPS (OTC)
K991315
Bayer Corp.
Chemistry · 207d
Cleared Jan 28, 1999
UALB
K983774
Abbott Laboratories
Chemistry · 94d
Cleared Aug 12, 1998
MICROALBUSTIX REAGENT STRIPS
K982219
Bayer Corp.
Chemistry · 49d
Cleared Aug 08, 1997
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA
K972337
Diagnostic Chemicals , Ltd.
Chemistry · 46d
Cleared Sep 27, 1996
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
K963142
Bayer Corp.
Chemistry · 45d
Cleared Apr 24, 1996
TOTAL PROTEIN (URINE)
K951222
Randox Laboratories, Ltd.
Chemistry · 401d
Cleared Jan 29, 1996
URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
K955438
Teco Diagnostics
Chemistry · 82d
Cleared Oct 26, 1995
CHEMSTRIP MICRAL URINE TEST STRIPS
K954346
Boehringer Mannheim Corp.
Chemistry · 38d
Cleared Feb 10, 1995
TINA-QUANT MICROALBUMIN
K932950
Boehringer Mannheim Corp.
Chemistry · 603d
Cleared Mar 11, 1992
SYN ELISA MICRO ALBUMIN
K920216
Elias U.S.A., Inc.
Chemistry · 55d
Cleared Apr 12, 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752
Boehringer Mannheim Corp.
Chemistry · 175d
Cleared Aug 22, 1990
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
K902204
Stanbio Laboratory
Chemistry · 98d
Cleared Sep 18, 1989
BIOTEL MICROALBUMINURIA (TM)
K894169
American Diagnostic Corp.
Chemistry · 95d
Cleared Mar 21, 1989
BIOTROL URINE PROTEINS REAGENT
K890846
Biotrol, USA, Inc.
Chemistry · 28d
Cleared Jan 30, 1989
BIOTROL URINE PROTEINS REAGENT
K885053
Biotrol, USA, Inc.
Chemistry · 54d
Cleared Apr 28, 1988
MICRO-BUMINTEST REAGENT TABLETS
K874909
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Apr 07, 1986
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338
Diagnostic Products Corp.
Chemistry · 369d

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 1 in the prior period.