Lowry (Colorimetric), Total Protein
FDA product code JGP · Class II (moderate risk) · 21 CFR 862.1635 · Clinical Chemistry
5510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | Pointe Scientific, Inc., | 12/04/2007SE |
| K964960 | Vitros Chemistry Products Upro SlidesJGP · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 02/18/1997SE |
| K863112 | ProteinmeterJGP · Traditional | J. D. Assoc. | 12/10/1986SE |
| K821534 | Hematology Data Management SysJGP · Traditional | Biovation, Inc. | 06/10/1982SE |
| K792347 | Micro Lowry ProteintestJGP · Traditional | Panmed, Inc. | 12/06/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1179-2017 Class II | VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative…There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO… | Ortho-Clinical Diagnostics | 12/08/2016Terminated |
| Z-0327-2014 Class II | VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |