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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)
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Top companies in CEK

Company510(k)sRecalls
Em Diagnostic Systems, Inc.100
Harleco60
Siemens Healthcare Diagnostics, Inc.06
Beckman Instruments, Inc.40
Data Medical Associates, Inc.40
Ortho Clinical Diagnostics Inc04
Medical Analysis Systems, Inc.30
Wako Chemicals USA, Inc.30
Abbott Laboratories20
American Monitor Corp.20
DateFirm and productCodeLinked 510(k)
Sep 8, 2025Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Open, Classified		 CEKNone listed
Sep 6, 2024Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Open, Classified		 CEKNone listed
Sep 6, 2024Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Open, Classified		 CEKNone listed
Aug 29, 2023Siemens 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		 CEKNone listed
Sep 20, 2021Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
Open, Classified		 CEKNone listed
Sep 20, 2021Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Open, Classified		 CEKNone listed
Dec 15, 2020Ortho 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		 CEKNone listed
Dec 15, 2020Ortho 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		 CEKNone listed
Nov 15, 2013Ortho-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		 CEKNone listed
Jun 5, 2003Ortho-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		 CEKK812028

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