Turbidimetric, Total Protein
FDA product code JGQ · Class II (moderate risk) · 21 CFR 862.1635 · Clinical Chemistry
13510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131051 | Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)JGQ · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K072638 | Roche/Hitachi Urinary/Csf Protein with Model(S) Cat #11877801JGQ · Special | Roche Diagnostics Corp. | 10/19/2007SE |
| K071239 | Total Protein Urine/Csf GEN.3JGQ · Special | Roche Diagnostics | 09/14/2007SE |
| K981295 | UproJGQ · Traditional | Abbott Laboratories | 10/01/1998SE |
| K981682 | UproJGQ · Traditional | Abbott Laboratories | 09/21/1998SE |
| K925794 | Trace Microprotein ReagentJGQ · Traditional | Trace America, Inc. | 03/29/1993SE |
| K913615 | Urinary/Csf ProteinJGQ · Traditional | Boehringer Mannheim Corp. | 09/13/1991SE |
| K903914 | Paramax Cerebrospinal Fluid/Urine Protein BlankJGQ · Traditional | Baxter Healthcare Corp | 10/03/1990SE |
| K901083 | Emds(Tm) Cerebrospinal Fluid Protein, #67668/95JGQ · Traditional | Em Diagnostic Systems, Inc. | 04/16/1990SE |
| K863478 | Cerebrospinal Fluid Protein Testpack, #67668/95JGQ · Traditional | Em Diagnostic Systems, Inc. | 10/29/1986SE |
| K842134 | Somas Coomasie Blue Total Protein AssayJGQ · Traditional | Somas Medical Industries, Inc. | 07/06/1984SE |
| K822231 | Aca Urinary Protein Analytical Test PackJGQ · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/30/1982SE |
| K780110 | CSF Total Protein Test Set #0340JGQ · Traditional | Stanbio Laboratory | 03/03/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0017-2014 Class II | Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent…Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista… | Siemens Healthcare Diagnostics, Inc. | 12/19/2012Terminated |