The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay D-dimer Controls.
| Device ID | K012422 |
| 510k Number | K012422 |
| Device Name: | K-ASSAY D-DIMER CONTROLS |
| Classification | Control, Plasma, Abnormal |
| Applicant | KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Contact | Don Tran |
| Correspondent | Don Tran KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle, WA 98188 -3412 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2001-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020894 | K012422 | 000 |