The following data is part of a premarket notification filed by Immunetech Corporation with the FDA for Immunetech Total Ige System.
| Device ID | K032251 |
| 510k Number | K032251 |
| Device Name: | IMMUNETECH TOTAL IGE SYSTEM |
| Classification | Ige, Antigen, Antiserum, Control |
| 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 | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-22 |
| Decision Date | 2003-12-19 |
| Summary: | summary |