ClearanceBrief
Panels › Clinical Chemistry › Product code CKA · Class 1

Nadh Oxidation/Nad Reduction, Alt/Sgpt

Regulation 862.1030

0510(k)s in 12 months (127 all time)
0recalls in 12 months (18 all time)
10recalls that name a 510(k)
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Top companies in CKA

Company510(k)sRecalls
Em Diagnostic Systems, Inc.100
Pointe Scientific, Inc.,28
Abbott Laboratories34
Boehringer Mannheim Corp.50
American Monitor Corp.40
Beckman Instruments, Inc.40
Coulter Electronics, Inc.40
Harleco40
Technicon Instruments Corp.40
Trace Scientific , Ltd.40
DateFirm and productCodeLinked 510(k)
Jun 10, 2021Abbott Laboratories
REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Open, Classified		 CKANone listed
Jun 10, 2021Abbott Laboratories
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
Open, Classified		 CKANone listed
Jun 10, 2021Abbott Laboratories
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Open, Classified		 CKANone listed
Jun 10, 2021Abbott Laboratories
REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
Open, Classified		 CKANone listed
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CKANone listed
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CKANone listed
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase o
Terminated		 CKANone listed
Dec 29, 2016Sterling Diagnostics, Inc.
Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Terminated		 CKANone listed
Apr 30, 2014Alfa Wassermann, Inc.
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical
Terminated		 CKAK131351
Feb 9, 2011Abaxis, Incorporated
Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; Product is manufactured and dis
Terminated		 CKAK950164
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic, Pointe Scientific, Inc.; C
Terminated		 CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc
Terminated		 CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc
Terminated		 CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated		 CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated		 CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated		 CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated		 CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated		 CKAK941287

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