K983289 is an FDA 510(k) clearance for the APOLIPOPROTEIN A1. This device is classified as a Alpha-1-lipoprotein, Antigen, Antiserum, Control (Class II - Special Controls, product code DER).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on January 29, 1999, 133 days after receiving the submission on September 18, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5580.
| 510(k) Number | K983289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1998 |
| Decision Date | January 29, 1999 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DER — Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5580 |