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
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 |
| LGI | Fluorescence Polarization Immunoassay, Carbamazepine | 4 |
| KXT | Enzyme Immunoassay, Digoxin | 3 |
| LOM | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) | 3 |
| JIS | Calibrator, Primary | 2 |
| JIT | Calibrator, Secondary | 2 |
| LCQ | Fluorescent Immunoassay Gentamicin | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| LAO | Enzyme Immunoassay, Methotrexate | 1 |
| LCD | Enzyme Immunoassay, Gentamicin | 1 |
| LER | Fluorescent Immunoassay, Theophylline | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2008 | Abbott 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 |
KXT | K953718 |
| Jul 24, 2008 | Abbott 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 |
JIS | K952148 |
| Feb 26, 2008 | Abbott 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 |
LCD | K935376 |
| Feb 26, 2008 | Abbott 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 |
LCQ | K801084 |
| Feb 26, 2008 | Abbott 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 |
LCQ | K801084 |
| Nov 3, 2007 | Abbott 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 |
KXT | K061249 |
| Aug 29, 2007 | Abbott Diagnostic International, Ltd. Abbott AxSYM System Digoxin III Reagent Pack Terminated |
KXT | K061249 |
| Aug 22, 2007 | Abbott 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 |
LGI | K940682 |
| Aug 22, 2007 | Abbott Diagnostic International, Ltd. XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each).-Product List Number-9506-01 Terminated |
LGI | K940682 |
| Aug 22, 2007 | Abbott 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 |
LGI | K940682 |
| Aug 22, 2007 | Abbott 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 |
LGI | K940682 |
| Jul 24, 2007 | Abbott 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 |
LOM | None listed |
| Jul 24, 2007 | Abbott 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 |
LOM | None listed |
| Jul 24, 2007 | Abbott 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 |
LOM | None listed |
| Jul 20, 2007 | Abbott 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 |
LAO | K932615 |
| Jul 12, 2007 | Abbott Diagnostic International, Ltd. Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing animal serum. Terminated |
JHI | K935673 |
| Jul 12, 2007 | Abbott 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 |
JHI | K935673 |
| Jul 12, 2007 | Abbott 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 |
JHI | K935673 |
| Jul 12, 2007 | Abbott 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 |
JHI | K935673 |
| Jul 3, 2007 | Abbott 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 |
LER | K833070 |
| Nov 17, 2006 | Abbott Diagnostic International, Ltd. Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 Terminated |
JJE | K041811 K974651 |
| Oct 12, 2006 | Abbott Diagnostic International, Ltd. Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use. Terminated |
JIT | K032458 |
| Oct 12, 2006 | Abbott Diagnostic International, Ltd. FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. Terminated |
JIT | K032458 |
| Oct 12, 2006 | Abbott Diagnostic International, Ltd. Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use. Terminated |
JIS | K935612 |