The following data is part of a premarket notification filed by Immunetech Corporation with the FDA for My Allergy Test.
| Device ID | K021698 |
| 510k Number | K021698 |
| Device Name: | MY ALLERGY TEST |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| 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 | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-22 |
| Decision Date | 2002-09-19 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MY ALLERGY TEST 78118234 not registered Dead/Abandoned |
Kriese, George, Edward, Jr. 2002-03-28 |