The following data is part of a premarket notification filed by Immunetech Corporation with the FDA for Modification To Myallergy Test.
| Device ID | K061979 |
| 510k Number | K061979 |
| Device Name: | MODIFICATION TO MYALLERGY TEST |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | IMMUNETECH CORPORATION 888 OAK GROVE, SUITE 4 Menlo Park, CA 94025 |
| Contact | Nancy Benson |
| Correspondent | Nancy Benson IMMUNETECH CORPORATION 888 OAK GROVE, SUITE 4 Menlo Park, CA 94025 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-13 |
| Decision Date | 2006-09-22 |
| Summary: | summary |