The following data is part of a premarket notification filed by Mast Immunosystems with the FDA for Inhalant Profile-allergen-specific Ige.
| Device ID | K823593 |
| 510k Number | K823593 |
| Device Name: | INHALANT PROFILE-ALLERGEN-SPECIFIC IGE |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | MAST IMMUNOSYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-06 |
| Decision Date | 1983-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813382010334 | K823593 | 000 |
| 00813382010167 | K823593 | 000 |
| 00813382010150 | K823593 | 000 |
| 00813382010143 | K823593 | 000 |
| 00813382010136 | K823593 | 000 |
| 00813382010129 | K823593 | 000 |
| 00813382010105 | K823593 | 000 |