The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Auto-lyte Urinary Glucose Assay.
| Device ID | K962435 |
| 510k Number | K962435 |
| Device Name: | STC AUTO-LYTE URINARY GLUCOSE ASSAY |
| Classification | Hexokinase, Glucose |
| Applicant | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | Lisa Vail |
| Correspondent | Lisa Vail ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1996-12-26 |