ClearanceBrief
Company

Abbott Diagnostic International, Ltd.

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
24recalls (0 in 12 months)
21recalls that name a 510(k)

Product codes

CodeDeviceRecords
JHIVisual, Pregnancy Hcg, Prescription Use4
LGIFluorescence Polarization Immunoassay, Carbamazepine4
KXTEnzyme Immunoassay, Digoxin3
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)3
JISCalibrator, Primary2
JITCalibrator, Secondary2
LCQFluorescent Immunoassay Gentamicin2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1
LAOEnzyme Immunoassay, Methotrexate1
LCDEnzyme Immunoassay, Gentamicin1
LERFluorescent Immunoassay, Theophylline1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 21, 2008Abbott Diagnostic International, Ltd.
AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascul
Terminated
KXTK953718
Jul 24, 2008Abbott Diagnostic International, Ltd.
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
Terminated
JISK952148
Feb 26, 2008Abbott Diagnostic International, Ltd.
Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle o
Terminated
LCDK935376
Feb 26, 2008Abbott Diagnostic International, Ltd.
Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein trac
Terminated
LCQK801084
Feb 26, 2008Abbott Diagnostic International, Ltd.
Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and
Terminated
LCQK801084
Nov 3, 2007Abbott Diagnostic International, Ltd.
Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphatase Conj
Terminated
KXTK061249
Aug 29, 2007Abbott Diagnostic International, Ltd.
Abbott AxSYM System Digoxin III Reagent Pack
Terminated
KXTK061249
Aug 22, 2007Abbott Diagnostic International, Ltd.
XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield dirrefent concentration ranges.-Product List Number
Terminated
LGIK940682
Aug 22, 2007Abbott Diagnostic International, Ltd.
XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product List Number-9506-01
Terminated
LGIK940682
Aug 22, 2007Abbott Diagnostic International, Ltd.
AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing quinidine prepared in human serum to yield the differ
Terminated
LGIK940682
Aug 22, 2007Abbott Diagnostic International, Ltd.
AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01
Terminated
LGIK940682
Jul 24, 2007Abbott Diagnostic International, Ltd.
ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.
Terminated
LOMNone listed
Jul 24, 2007Abbott Diagnostic International, Ltd.
Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the following companents: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic.
Terminated
LOMNone listed
Jul 24, 2007Abbott Diagnostic International, Ltd.
ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect AUSAB microparticles and 2) Architect AUSAB Conjugate. in vitro diagnostic.
Terminated
LOMNone listed
Jul 20, 2007Abbott Diagnostic International, Ltd.
TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antib
Terminated
LAOK932615
Jul 12, 2007Abbott Diagnostic International, Ltd.
Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum.
Terminated
JHIK935673
Jul 12, 2007Abbott Diagnostic International, Ltd.
IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bo
Terminated
JHIK935673
Jul 12, 2007Abbott Diagnostic International, Ltd.
AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B- hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF
Terminated
JHIK935673
Jul 12, 2007Abbott Diagnostic International, Ltd.
AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7
Terminated
JHIK935673
Jul 3, 2007Abbott Diagnostic International, Ltd.
IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal)
Terminated
LERK833070
Nov 17, 2006Abbott Diagnostic International, Ltd.
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
Terminated
JJEK041811
K974651
Oct 12, 2006Abbott Diagnostic International, Ltd.
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Terminated
JITK032458
Oct 12, 2006Abbott Diagnostic International, Ltd.
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Terminated
JITK032458
Oct 12, 2006Abbott Diagnostic International, Ltd.
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Terminated
JISK935612
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