ClearanceBrief
Panels › Clinical Chemistry › Product code CIT · Class 2

Nadh Oxidation/Nad Reduction, Ast/Sgot

Regulation 862.1100

0510(k)s in 12 months (139 all time)
0recalls in 12 months (13 all time)
12recalls that name a 510(k)
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Top companies in CIT

Company510(k)sRecalls
Em Diagnostic Systems, Inc.100
Abbott Laboratories81
Roche Diagnostic Systems, Inc.60
American Monitor Corp.50
Coulter Electronics, Inc.40
Diagnostic Chemicals , Ltd.40
Pointe Scientific, Inc.,22
Sigma Diagnostics, Inc.40
Trace Scientific , Ltd.40
Amresco, Inc.30
DateFirm and productCodeLinked 510(k)
Oct 31, 2023Randox Laboratories Ltd.
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
Open, Classified		 CITK131554
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CITK061020
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CITK112999
May 18, 2017Medtest Holdings, Inc.
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination o
Terminated		 CITK941132
Oct 2, 2014ELITech Clinical Systems SAS
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate a
Terminated		 CITK102647
Apr 30, 2014Alfa Wassermann, Inc.
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical
Terminated		 CITK113382
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VIT
Terminated		 CITK001679
K934413
Jan 3, 2013Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by col
Terminated		 CITK060318
Apr 23, 2012Abbott Laboratories Inc.
ARCHITECT/AEROSET Activated Aspartate Aminotransferase The Activated Asparate Aminotransferase (Activated AST) assay is used for the quantitation of asparate aminotransferse in human serum or plasma
Terminated		 CITK071525
Oct 22, 2008Pointe Scientific, Inc.
AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum
Terminated		 CITK941132
Oct 22, 2008Pointe Scientific, Inc.
Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate
Terminated		 CITK941132
Sep 2, 2004Roche Diagnostics Corp.
Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1928511 (11928511216).
Terminated		 CITNone listed
Jul 31, 2004Roche Diagnostics Corp.
Roche brand Reflotron GPT (ALT) 30 test strips; catalog # 745138.
Terminated		 CITK864082

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