K993354 is an FDA 510(k) clearance for the K-ASSAY APO B. This device is classified as a Alpha-1-lipoprotein, Antigen, Antiserum, Control (Class II - Special Controls, product code DER).
Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on October 28, 1999, 23 days after receiving the submission on October 5, 1999.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5580.
| 510(k) Number | K993354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 1999 |
| Decision Date | October 28, 1999 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | DER — Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5580 |