Panels › Immunology › Product code DER · Class 2
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Regulation 866.5580
0510(k)s in 12 months (17 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in DER
| Company | 510(k)s | Recalls |
|---|---|---|
| Crestat Diagnostics, Inc. | 3 | 0 |
| Photec Diagnostics, Inc. | 3 | 0 |
| Abbott Laboratories | 1 | 1 |
| Kamiya Biomedical Co. | 2 | 0 |
| Roche Diagnostics Corp. | 2 | 0 |
| Abbott Laboratories Diagnostic Div | 0 | 1 |
| Bayer Corp. | 1 | 0 |
| Eucardio Laboratory, Inc. | 1 | 0 |
| Hyland Therapeutic Div., Travenol Laboratories | 1 | 0 |
| Roche Diagnostic Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Abbott Laboratories, Inc Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of
apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in th Terminated |
DER | K983289 |
| Jan 11, 2006 | Abbott Laboratories Diagnostic Div Clinical Chemistry Apolipoprotein A1, List Number 9D92-20 Terminated |
DER | K983289 |
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