The following data is part of a premarket notification filed by Gds Technology, Llc. with the FDA for Hemosite Test System.
| Device ID | K973649 |
| 510k Number | K973649 |
| Device Name: | HEMOSITE TEST SYSTEM |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | GDS TECHNOLOGY, LLC. 25235 LEER DR. Elkhart, IN 46514 |
| Contact | Jonathan A Kovach |
| Correspondent | Jonathan A Kovach GDS TECHNOLOGY, LLC. 25235 LEER DR. Elkhart, IN 46514 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1998-08-31 |
| Summary: | summary |