The following data is part of a premarket notification filed by Immunetech Corporation with the FDA for Myallergytest System.
| Device ID | K020387 |
| 510k Number | K020387 |
| Device Name: | MYALLERGYTEST SYSTEM |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| Applicant | IMMUNETECH CORPORATION P.O. BOX 9433 17394 VIA DEL BRAVO Rancho Santa Fe, CA 92067 |
| Contact | Vivianne Noetzel |
| Correspondent | Vivianne Noetzel IMMUNETECH CORPORATION P.O. BOX 9433 17394 VIA DEL BRAVO Rancho Santa Fe, CA 92067 |
| Product Code | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-05 |
| Decision Date | 2002-04-17 |
| Summary: | summary |