Panels › Clinical Chemistry › Product code JHS · Class 2
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (38 all time)
0recalls in 12 months (11 all time)
11recalls that name a 510(k)
Top companies in JHS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2024 | Roche Diagnostics Operations, Inc. Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma.
Catalog Number: 07190794 Open, Classified |
JHS | K160570 |
| Jan 5, 2021 | Ortho Clinical Diagnostics Inc VITROS Chemistry Products CKMB Slides:
(1)VITROS CKMB Slides (60 Slide cartridge)
Product Code:8058232
(2)VITROS CKMB Slides (18 Slide cartridge)
Product Code: 8001133
Quantitatively measure creat Open, Classified |
JHS | K861387 |
| Apr 1, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine k Terminated |
JHS | K861387 |
| Apr 1, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine Terminated |
JHS | K861387 |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc Atellica IM CKMB Master Curve Material, Cat No. 10995534
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown Terminated |
JHS | K962126 |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc Atellica IM CKMB Calibrator, Cat No. 10995532
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples af Terminated |
JHS | K962126 |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768
Product Usage:
For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unkno Terminated |
JHS | K962126 |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748
Product Usage:
For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. Terminated |
JHS | K962126 |
| Jul 24, 2018 | Siemens Healthcare Diagnostics, Inc ADVIA Centaur CKMB Calibrator, Cat No. 09318028
Product Usage:
For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. Terminated |
JHS | K962126 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133
VITROS CK Slides quantitatively measure creatine kinase Terminated |
JHS | K861387 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034
VITROS CK Slides quantitatively measure creatine kinase (CK Terminated |
JHS | K922072 |
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