The following data is part of a premarket notification filed by Gds Technology, Llc. with the FDA for Glucosite Test System.
| Device ID | K971145 |
| 510k Number | K971145 |
| Device Name: | GLUCOSITE TEST SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | GDS TECHNOLOGY, LLC. 25235 LEER DR. Elkhart, IN 46514 |
| Contact | John W Swatosh |
| Correspondent | John W Swatosh GDS TECHNOLOGY, LLC. 25235 LEER DR. Elkhart, IN 46514 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-28 |
| Decision Date | 1997-09-17 |
| Summary: | summary |