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Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Regulation 862.1215

0510(k)s in 12 months (123 all time)
1recalls in 12 months (10 all time)
8recalls that name a 510(k)
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Top companies in CGS

Company510(k)sRecalls
Em Diagnostic Systems, Inc.140
Abbott Laboratories43
Helena Laboratories70
Siemens Healthcare Diagnostics34
Harleco60
Randox Laboratories, Ltd.31
Diagnostic Chemicals , Ltd.30
Emd Chemicals, Inc.30
Reagents Applications, Inc.30
Sclavo, Inc.30
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
NAD Profile Test
Open, Classified		 CGSNone listed
Mar 25, 2022Randox Laboratories Ltd.
CK MB Calibrator, Catalogue Number CK2393
Terminated		 CGSNone listed
May 3, 2019Siemens Healthcare Diagnostics, Inc.
Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the qu
Terminated		 CGSK160724
May 3, 2019Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in th
Terminated		 CGSK160724
Jul 18, 2018Abbott Laboratories, Inc
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Terminated		 CGSK983070
Jul 18, 2018Abbott Laboratories, Inc
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
Terminated		 CGSK983070
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CGSK083465
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CGSK081731
Jun 29, 2017Medtest Holdings, Inc.
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of cre
Terminated		 CGSK972155
Mar 19, 2008Abbott Laboratories Inc.
Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Lot Number: 52044HW00; Expires October 19, 2007, RCR#2018433-10/25/07-006R Abbott Laboratories, Inc., South Pasadena CA 91030
Terminated		 CGSK983070

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