The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Hema-screen Specific Gold.
| Device ID | K171484 |
| 510k Number | K171484 |
| Device Name: | Hema-screen SPECIFIC Gold |
| Classification | Reagent, Occult Blood |
| Applicant | Immunostics, Inc. 1750 Brielle Ave. Suite A5 Ocean, NJ 07712 |
| Contact | Elizabeth Galella |
| Correspondent | Elizabeth Galella Immunostics, Inc. 1750 Brielle Ave. Suite A5 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 | 2017-05-22 |
| Decision Date | 2017-06-14 |
| Summary: | summary |