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 |