The following data is part of a premarket notification filed by Mast Immunosystems with the FDA for Mast Luminescent Allergy Sys.
| Device ID | K841642 |
| 510k Number | K841642 |
| Device Name: | MAST LUMINESCENT ALLERGY SYS |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | MAST IMMUNOSYSTEMS MD |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-20 |
| Decision Date | 1984-06-07 |