The following data is part of a premarket notification filed by Mast Immunosystems with the FDA for Mast Cla Allergy System.
| Device ID | K910292 |
| 510k Number | K910292 |
| Device Name: | MAST CLA ALLERGY SYSTEM |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | MAST IMMUNOSYSTEMS 630 CLYDE CT. Mountain View, CA 94043 |
| Contact | Richard A Harte |
| Correspondent | Richard A Harte 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 | 1991-01-23 |
| Decision Date | 1991-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813382010198 | K910292 | 000 |
| 00813382010181 | K910292 | 000 |