The following data is part of a premarket notification filed by Hitachi Chemical Diagnostics, Inc. with the FDA for Optigen Allergen Specific Ige Assay.
| Device ID | K051677 |
| 510k Number | K051677 |
| Device Name: | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Contact | Emi Zychlinsky |
| Correspondent | Emi Zychlinsky HITACHI CHEMICAL DIAGNOSTICS, INC. 630 CLYDE CT. Mountain View, CA 94043 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-21 |
| Decision Date | 2006-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813382010396 | K051677 | 000 |
| 00813382010389 | K051677 | 000 |
| 00813382010372 | K051677 | 000 |
| 00813382010358 | K051677 | 000 |
| 00813382010280 | K051677 | 000 |
| 00813382010099 | K051677 | 000 |
| 00813382010082 | K051677 | 000 |
| 00813382010075 | K051677 | 000 |
| 00813382010006 | K051677 | 000 |