The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Hema-screen Er Xcel Enhanced Readability Fecal Occult Blood Test.
| Device ID | K163554 |
| 510k Number | K163554 |
| Device Name: | Hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test |
| Classification | Reagent, Occult Blood |
| Applicant | Immunostics, Inc. 1750 Brielle Ave., AS Ocean, NJ 07712 |
| Contact | Antoinette Prusik |
| Correspondent | Antoinette Prusik Immunostics, Inc. 1750 Brielle Ave., AS Ocean, NJ 07712 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-01-17 |
| Summary: | summary |