The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Hemochroma Plus System.
| Device ID | K163465 |
| 510k Number | K163465 |
| Device Name: | Hemochroma PLUS System |
| Classification | System, Hemoglobin, Automated |
| Applicant | IMMUNOSTICS, INC. 1750 BRIELLE AVE. A5 Ocean, NJ 07712 |
| Contact | Antoinette Prusik |
| Correspondent | Antoinette Prusik IMMUNOSTICS, INC. 1750 BRIELLE AVE. A5 Ocean, NJ 07712 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-09-08 |
| Summary: | summary |