The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Myoglobin Assay, K-assay Myoglobin Calibrator.
| Device ID | K992976 |
| 510k Number | K992976 |
| Device Name: | K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR |
| Classification | Myoglobin, 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 | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-03 |
| Decision Date | 1999-11-01 |