The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Total Ige, K-assay Ige Calibrator Set, Models Kai-092/kai-093c.
| Device ID | K042241 |
| 510k Number | K042241 |
| Device Name: | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. Seattle, WA 98168 |
| Contact | Brian Schliesman |
| Correspondent | Brian Schliesman KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. Seattle, WA 98168 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-19 |
| Decision Date | 2004-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020672 | K042241 | 000 |
| 00816426020375 | K042241 | 000 |