The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Lp(a) Assay.
| Device ID | K021660 |
| 510k Number | K021660 |
| Device Name: | K-ASSAY LP(A) ASSAY |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Contact | Brian Schliesman |
| Correspondent | Brian Schliesman KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-20 |
| Decision Date | 2002-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020573 | K021660 | 000 |
| 00816426020245 | K021660 | 000 |
| 00816426020122 | K021660 | 000 |