Company
Abbott Laboratories Diagnostic Div
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)
13recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DFT | Igm, Antigen, Antiserum, Control | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 1 |
| JGJ | Photometric Method, Magnesium | 1 |
| JZJ | Prealbumin, Antigen, Antiserum, Control | 1 |
| LGQ | Fluorescence Polarization Immunoassay, Phenobarbital | 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) |
|---|---|---|---|
| Feb 14, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Multiconstituent Calibrator---
List number: lE65-02 Terminated |
JIX | K981706 |
| Jan 11, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Prealbumin, List Number 1E02-20 Terminated |
JZJ | None listed |
| Jan 11, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Immunoglobulin M, List Number 1E01-20 Terminated |
DFT | K983132 |
| Jan 11, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Apolipoprotein A1, List Number 9D92-20 Terminated |
DER | K983289 |
| Aug 24, 2005 | Abbott Laboratories Diagnostic Div Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100 Terminated |
JIX | None listed |
| Aug 17, 2004 | Abbott Laboratories Diagnostic Div Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20 Terminated |
CGX | K981799 |
| Jul 20, 2004 | Abbott Laboratories Diagnostic Div Clinical Chemistry Uric Acid; LN 7D76-20 Terminated |
CDO | None listed |
| Jul 20, 2004 | Abbott Laboratories Diagnostic Div AEROSET Phenobarbital, LN 1E08-01 Terminated |
LGQ | None listed |
| Jul 20, 2004 | Abbott Laboratories Diagnostic Div AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA Terminated |
DFT | K982132 |
| Feb 26, 2004 | Abbott Laboratories Diagnostic Div Clinical Chemistry Urea Nitrogen Terminated |
None listed | |
| Jan 16, 2004 | Abbott Laboratories Diagnostic Div Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30. Terminated |
JGJ | None listed |
| Dec 18, 2003 | Abbott Laboratories Diagnostic Div AEROSET/ARCHITECT c8000 Urea Nitrogen
Models: 7D75-01; 7D75-20; 7D75-30 Terminated |
CDQ | None listed |
| May 9, 2003 | Abbott Laboratories Diagnostic Div Aeroset Direct HDL Reagent, LN 7D67-01 Terminated |
K981580 |