Panels › Clinical Chemistry › Product code CEK · Class 2
Biuret (Colorimetric), Total Protein
Regulation 862.1635
0510(k)s in 12 months (116 all time)
0recalls in 12 months (10 all time)
1recalls that name a 510(k)
Top companies in CEK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2025 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. Open, Classified |
CEK | None listed |
| Sep 6, 2024 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151 Open, Classified |
CEK | None listed |
| Sep 6, 2024 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543 Open, Classified |
CEK | None listed |
| Aug 29, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer.
SMN: 11097604 Open, Classified |
CEK | None listed |
| Sep 20, 2021 | Siemens Healthcare Diagnostics, Inc. Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151 Open, Classified |
CEK | None listed |
| Sep 20, 2021 | Siemens Healthcare Diagnostics, Inc. Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 Open, Classified |
CEK | None listed |
| Dec 15, 2020 | Ortho Clinical Diagnostics Inc VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT Terminated |
CEK | None listed |
| Dec 15, 2020 | Ortho Clinical Diagnostics Inc VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Terminated |
CEK | None listed |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431
VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/3 Terminated |
CEK | None listed |
| Jun 5, 2003 | Ortho-Clinical Diagnostics Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label Terminated |
CEK | K812028 |
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