The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Afias Ifob With Afias-50.
| Device ID | K163225 |
| 510k Number | K163225 |
| Device Name: | AFIAS IFOB With AFIAS-50 |
| Classification | Automated Occult Blood Analyzer |
| Applicant | IMMUNOSTICS, INC. 1750 BRIELLE AVENUE, A5 Ocean, NJ 07712 |
| Contact | Antoinette Prusik |
| Correspondent | Antoinette Prusik IMMUNOSTICS, INC. 1750 BRIELLE AVENUE, A5 Ocean, NJ 07712 |
| Product Code | OOX |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-17 |
| Decision Date | 2017-08-08 |
| Summary: | summary |