The following data is part of a premarket notification filed by Gds Technology, Llc. with the FDA for Cholesite Test System.
| Device ID | K992132 |
| 510k Number | K992132 |
| Device Name: | CHOLESITE TEST SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | GDS TECHNOLOGY, LLC. 25235 LEER DR. Elkhart, IN 46514 |
| Contact | Keith Crawford |
| Correspondent | Keith Crawford GDS TECHNOLOGY, LLC. 25235 LEER DR. Elkhart, IN 46514 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-23 |
| Decision Date | 1999-08-20 |
| Summary: | summary |