Product code JIQ
- Device name
- Turbidimetric 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 |
|---|---|---|---|
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics Operations (Rdo) | 2014-12-09 |
| K013643 | AUSAM TOTAL ALBUMIN ASSAY | Ausam Biotecthnologies, Inc. | 2003-08-14 |
| K991800 | HEMOCHEK URINE COLLECTION KIT | Osborn Group, Inc. | 1999-09-24 |
| K971458 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT | Diagnostic Specialties | 1997-09-02 |
| K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT | Beckman Instruments, Inc. | 1997-04-17 |
| K944664 | WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR | Wako Chemicals USA, Inc. | 1995-02-07 |
| K936202 | URINARY ALBUMIN TEST PACK | Dupont Medical Products | 1994-05-09 |
| K935662 | SYNERMED IR 500 CHEMISTRY ANALYZER | Synermed, Inc. | 1994-04-26 |
| K903123 | RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT | Reagents Applications, Inc. | 1990-09-14 |
| K902216 | WAKO(TM) MICRO-ALBUMIN | Wako Chemicals USA, Inc. | 1990-06-18 |
| K895883 | BECKMAN MA MICROALBUMIN REAGENT KIT | Beckman Instruments, Inc. | 1989-12-27 |
| K870516 | ALBUMIN SCREEN TEST | Sclavo, Inc. | 1987-10-20 |
| K842915 | SULFOSALICYLIC ACID, 3% W/V | E K Ind., Inc. | 1984-08-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740190316 | ARCHITECT | ABBOTT IRELAND | 2022-05-25 |
| 00380740190781 | Alinity | ABBOTT IRELAND | 2022-02-28 |
| 04987481164666 | Autokit Micro Albumin | FUJIFILM WAKO PURE CHEMICAL CORPORATION | 2021-07-30 |
| 00192024068552 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024031143 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024031150 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 00192024068545 | Ricca Chemical Company® | Ricca Chemical Company, LLC | 2021-02-04 |
| 03610230008621 | Yumizen C1200 Urinary Proteins | HORIBA ABX SAS | 2020-09-09 |
| 00380740135201 | Alinity | Abbott GmbH | 2018-08-31 |
| 00380740119416 | ARCHITECT | Abbott GmbH | 2017-01-31 |
| 00380740119393 | ARCHITECT | Abbott GmbH | 2016-12-31 |
| 00380740119409 | ARCHITECT | Abbott GmbH | 2016-12-31 |
| 05060500090005 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | 2016-09-20 |
| 00380740003647 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740003654 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740003630 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 15099590180164 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 03610230005057 | ABX PENTRA URINARY PROTEINS CP | HORIBA ABX SAS | 2016-08-23 |