The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Apo B.
| Device ID | K993354 |
| 510k Number | K993354 |
| Device Name: | K-ASSAY APO B |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Contact | Colin Getty |
| Correspondent | Colin Getty KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-05 |
| Decision Date | 1999-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020177 | K993354 | 000 |
| 00816426020030 | K993354 | 000 |