The following data is part of a premarket notification filed by Mast Immunosystems with the FDA for Total Ige Mastick.
| Device ID | K870966 |
| 510k Number | K870966 |
| Device Name: | TOTAL IGE MASTICK |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | MAST IMMUNOSYSTEMS 630 CLYDE CT. Mountain View, CA 94043 |
| Contact | Steven P Miller,phd |
| Correspondent | Steven P Miller,phd MAST IMMUNOSYSTEMS 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 | 1987-03-10 |
| Decision Date | 1987-04-14 |