The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Microalbumin And K-assay Microalbumin Calibrator.
| Device ID | K091486 |
| 510k Number | K091486 |
| Device Name: | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR |
| Classification | Albumin, Antigen, Antiserum, Control |
| Applicant | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. Seattle, WA 98168 |
| Contact | Shawn Kaplan |
| Correspondent | Shawn Kaplan KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. Seattle, WA 98168 |
| Product Code | DCF |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-19 |
| Decision Date | 2010-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020443 | K091486 | 000 |
| 00816426020290 | K091486 | 000 |
| 00816426020139 | K091486 | 000 |
| 15099590010645 | K091486 | 000 |