The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Stc Diagnostics Auto-lyte Creatinine Assay.
| Device ID | K954266 |
| 510k Number | K954266 |
| Device Name: | STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R. Sam Niedbala |
| Correspondent | R. Sam Niedbala SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-12 |
| Decision Date | 1995-10-13 |