The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay At-iii.
| Device ID | K000361 |
| 510k Number | K000361 |
| Device Name: | K-ASSAY AT-III |
| Classification | Antithrombin Iii Quantitation |
| 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 | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-04 |
| Decision Date | 2000-04-26 |