Product code JIR
- Device name
- Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1645
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | 2023-09-08 |
| K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | 2022-07-06 |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | ACON Laboratories, Inc. | 2015-04-30 |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Teco Diagnostics | 2007-01-26 |
| K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 |
| K001810 | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING | Flexsite Diagnostics, Inc. | 2000-08-14 |
| K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 | Diagnostic Chemicals , Ltd. | 2000-02-01 |
| K992257 | NEW MULTIPLES REAGENT STRIPS | Bayer Corp. | 1999-11-24 |
| K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) | Bayer Corp. | 1999-11-12 |
| K983774 | UALB | Abbott Laboratories | 1999-01-28 |
| K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE | Tcpi, Inc. | 1998-10-07 |
| K982219 | MICROALBUSTIX REAGENT STRIPS | Bayer Corp. | 1998-08-12 |
| K972337 | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA | Diagnostic Chemicals , Ltd. | 1997-08-08 |
| K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY | American Laboratory Products Co., Ltd. | 1997-04-08 |
| K963142 | DCA 2000 + MICROALBUMIN/CREATININE ASSAY | Bayer Corp. | 1996-09-27 |
| K951222 | TOTAL PROTEIN (URINE) | Randox Laboratories, Ltd. | 1996-04-24 |
| K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY | Orgentec | 1996-03-29 |
| K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) | Teco Diagnostics | 1996-01-29 |
| K954346 | CHEMSTRIP MICRAL URINE TEST STRIPS | Boehringer Mannheim Corp. | 1995-10-26 |
| K932950 | TINA-QUANT MICROALBUMIN | Boehringer Mannheim Corp. | 1995-02-10 |
| K934146 | N-ASSAY TIA MICROALBUMIN | Crestat Diagnostics, Inc. | 1994-01-11 |
| K922032 | ENZIP URINARY MICROALBUMIN TEST | Diagnostic Specialties | 1992-07-30 |
| K920216 | SYN ELISA MICRO ALBUMIN | Elias U.S.A., Inc. | 1992-03-11 |
| K912246 | TARGET MICROALBUMINURIA TEST | Texas Immunology, Inc. | 1991-07-19 |
| K912543 | MICRO ALBUMIN EIA TEST KIT | Immuno Diagnostic Center, Inc. | 1991-07-19 |
| K904752 | CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS | Boehringer Mannheim Corp. | 1991-04-12 |
| K902204 | STANBIO CSF/URINE TOTAL PROTEIN TEST SET | Stanbio Laboratory | 1990-08-22 |
| K896440 | KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT | Kenlor Industries, Inc. | 1990-02-16 |
| K894169 | BIOTEL MICROALBUMINURIA (TM) | American Diagnostic Corp. | 1989-09-18 |
| K891544 | DIALBUMIN | Exocell, Inc. | 1989-06-09 |
Related GUDID Devices#
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|---|---|---|---|
| 10612479279886 | Mckesson | MCKESSON MEDICAL-SURGICAL INC. | 2025-09-18 |
| 08806141303497 | One+Step 10A | DFI CO.,LTD | 2023-10-16 |
| 08806141302209 | Just Fitter 10 Parameter Test Strips | DFI CO.,LTD | 2020-09-22 |
| 08806141302070 | CYBOW 10 | DFI CO.,LTD | 2020-06-29 |
| 08806141301998 | Yodoc 10 | DFI CO.,LTD | 2020-02-20 |
| 08806141301479 | QTEST™ 11 | DFI CO.,LTD | 2018-12-21 |
| 08806125680279 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 08806125680286 | UCARE 11 Stick | YD Diagnostics CORP. | 2017-07-28 |
| 10673486000245 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2017-01-05 |
| 08806125680217 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-12-21 |
| 10607415002062 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10612479197494 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479197463 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183527 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183497 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479183466 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10607415002055 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 10607415001294 | Moore Medical | MOORE MEDICAL LLC | 2016-12-09 |
| 08806141300755 | CYBOW 11 | DFI CO.,LTD | 2016-10-06 |
| 10673486000016 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000023 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000030 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000047 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000054 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000061 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 10673486000078 | TECO DIAGNOSTICS | TECO DIAGNOSTICS | 2016-09-27 |
| 08806125680064 | URiSCAN 6 L strip | YD Diagnostics CORP. | 2016-09-01 |
| 08806125680033 | URiSCAN 2 GP strip | YD Diagnostics CORP. | 2016-09-01 |
| 08806125680019 | URiSCAN 10 SGL strip | YD Diagnostics CORP. | 2016-08-05 |
| 08806125680231 | URiSCAN 10 ACR strip | YD Diagnostics CORP. | 2016-08-05 |