TOTAL PROTEIN URINE/CSF GEN.3
FDA 510(k) clearance K141925 · decided 2014-12-09
Clearance details
- K-number
- K141925
- Device name
- TOTAL PROTEIN URINE/CSF GEN.3
- Applicant
- Roche Diagnostics Operations (Rdo)
- Decision
- Substantially Equivalent
- Date received
- 2014-07-16
- Decision date
- 2014-12-09
- Days to decision
- 146 days
- Clearance type
- Special
- Product code
- JIQ
- Device class
- 1
- Regulation number
- 862.1645
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AUSAM TOTAL ALBUMIN ASSAY (K013643) | Ausam Biotecthnologies, Inc. | 2003-08-14 |
| HEMOCHEK URINE COLLECTION KIT (K991800) | Osborn Group, Inc. | 1999-09-24 |
| ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (K971458) | Diagnostic Specialties | 1997-09-02 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT (K965035) | Beckman Instruments, Inc. | 1997-04-17 |
| WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (K944664) | Wako Chemicals USA, Inc. | 1995-02-07 |
| URINARY ALBUMIN TEST PACK (K936202) | Dupont Medical Products | 1994-05-09 |
| SYNERMED IR 500 CHEMISTRY ANALYZER (K935662) | Synermed, Inc. | 1994-04-26 |
| RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT (K903123) | Reagents Applications, Inc. | 1990-09-14 |
| WAKO(TM) MICRO-ALBUMIN (K902216) | Wako Chemicals USA, Inc. | 1990-06-18 |
| BECKMAN MA MICROALBUMIN REAGENT KIT (K895883) | Beckman Instruments, Inc. | 1989-12-27 |
| ALBUMIN SCREEN TEST (K870516) | Sclavo, Inc. | 1987-10-20 |
| SULFOSALICYLIC ACID, 3% W/V (K842915) | E K Ind., Inc. | 1984-08-10 |
Recalls involving this device
No recalls on record reference this clearance.