The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Hema Screen Specific Ifobt.
| Device ID | K060463 |
| 510k Number | K060463 |
| Device Name: | HEMA SCREEN SPECIFIC IFOBT |
| Classification | Reagent, Occult Blood |
| Applicant | IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-22 |
| Decision Date | 2006-06-06 |