The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Hemochroma Plus System.
| Device ID | K182298 |
| 510k Number | K182298 |
| Device Name: | Hemochroma PLUS System |
| Classification | System, Hemoglobin, Automated |
| Applicant | Immunostics, Inc. 38 Industrial Way East, Suite1 Eatontown, NJ 07724 |
| Contact | Junghee Kim |
| Correspondent | Junghee Kim Immunostics, Inc. 38 Industrial Way East, Suite1 Eatontown, NJ 07724 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-24 |
| Decision Date | 2018-11-16 |
| Summary: | summary |