Product code JGQ
- Device name
- Turbidimetric, Total Protein
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1635
- 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 |
|---|---|---|---|
| K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| K072638 | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | Roche Diagnostics Corp. | 2007-10-19 |
| K071239 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics | 2007-09-14 |
| K981295 | UPRO | Abbott Laboratories | 1998-10-01 |
| K981682 | UPRO | Abbott Laboratories | 1998-09-21 |
| K925794 | TRACE MICROPROTEIN REAGENT | Trace America, Inc. | 1993-03-29 |
| K913615 | URINARY/CSF PROTEIN | Boehringer Mannheim Corp. | 1991-09-13 |
| K903914 | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK | Baxter Healthcare Corp | 1990-10-03 |
| K901083 | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 | Em Diagnostic Systems, Inc. | 1990-04-16 |
| K863478 | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 | Em Diagnostic Systems, Inc. | 1986-10-29 |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Somas Medical Industries, Inc. | 1984-07-06 |
| K822231 | ACA URINARY PROTEIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1982-09-30 |
| K780110 | CSF TOTAL PROTEIN TEST SET #0340 | Stanbio Laboratory | 1978-03-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740161798 | ARCHITECT | Abbott GmbH | 2020-04-18 |
| 00380740161804 | ARCHITECT | Abbott GmbH | 2020-04-18 |
| 07613336121535 | Total Protein Urine/CSF Gen.3 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740135317 | Alinity | Abbott GmbH | 2019-05-07 |
| 00380740135300 | Alinity | Abbott GmbH | 2018-11-07 |
| 04015630919536 | Total Protein UrineCSF Gen3 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630925179 | Total Protein UrineCSF Gen3 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630936441 | Protein Total Protein in UrineCerebrospinal Fluid | Roche Diagnostics GmbH | 2016-09-20 |
| 00845275003239 | Thermo Scientific Infinity™ | Fisher Diagnostics | 2016-09-16 |
| 00380740013028 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740013035 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |