Panels › Clinical Chemistry › Product code JFY · Class 2
Enzymatic Method, Creatinine
Regulation 862.1225
1510(k)s in 12 months (49 all time)
0recalls in 12 months (29 all time)
29recalls that name a 510(k)
Top companies in JFY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2020 | Ortho-Clinical Diagnostics VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS
In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931 Terminated |
JFY | K182063 |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine Terminated |
JFY | K090330 |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for t Terminated |
JFY | K073055 |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine f Terminated |
JFY | K070727 |
| Jun 5, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and uri Terminated |
JFY | K070727 |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 Terminated |
JFY | K090330 |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 Terminated |
JFY | K073055 |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 Terminated |
JFY | K070727 |
| Jan 24, 2020 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 Terminated |
JFY | K070727 |
| Aug 15, 2019 | Beckman Coulter Inc Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733 Terminated |
JFY | K091742 |
| Jul 11, 2018 | Ortho-Clinical Diagnostics VITROS Chemistry Products CREA Slides, Product Code 680 2584
Product Usage:
VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quant Terminated |
JFY | K063591 |
| Jun 27, 2017 | Sentinel CH SPA MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems
Terminated |
JFY | K073634 |
| Apr 3, 2017 | Beckman Coulter Inc. Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298.
Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine. Terminated |
JFY | K093458 |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Assays: Enzymatic Creatine (ECRE) Terminated |
JFY | K090330 |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. Dimension Assays: ENZYMATIC CREATININE Terminated |
JFY | K073055 |
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA CHEMISTRY ENZYMATIC CREATININE_2 Terminated |
JFY | K070727 |
| Sep 5, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determi Terminated |
JFY | K061238 K925668 |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. Creatinine Plus ver. 2.
Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine. Terminated |
JFY | K003261 |
| Apr 23, 2014 | Ortho-Clinical Diagnostics VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721 Terminated |
JFY | K071216 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584
VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VIT Terminated |
JFY | K063591 |
| Jun 28, 2012 | Polymer Technology Systems, Inc. PTS Panels Creatinine test strips.
PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidne Terminated |
JFY | K010456 |
| May 10, 2011 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Terminated |
JFY | K073055 |
| May 9, 2011 | Siemens Healthcare Diagnostics, Inc. Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System
The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in h Terminated |
JFY | K090330 |
| Sep 16, 2010 | Siemens Healthcare Diagnostics, Inc. Dimension Vista ECREA Flex Reagent Cartridge
The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista Syst Terminated |
JFY | K090330 |
| Mar 16, 2010 | Abaxis Inc Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc Terminated |
JFY | K942782 |
| Sep 30, 2009 | Diagnostic Chemicals, Ltd. DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP. Terminated |
JFY | K070383 |
| Sep 30, 2009 | Diagnostic Chemicals, Ltd. DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30.
In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine. Terminated |
JFY | K070383 |
| Dec 13, 2008 | Dade Behring, Inc. Dimension Enzymatic Creatinine Flex reagent cartridge, DF270.
The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Terminated |
JFY | K073055 |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190.
An in-vitro diagnostic reagent system intended for use on COBAS Int Terminated |
JFY | K024098 |
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