The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Stc Diagnostics Auto-lyte Opiate Eia.
| Device ID | K921328 |
| 510k Number | K921328 |
| Device Name: | STC DIAGNOSTICS AUTO-LYTE OPIATE EIA |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | SOLARCARE TECHNOLOGIES CORP,INC. BEN FRANKLIN TECHNOLOGY CENTER 115 RESEARCH DRIVE Bethlehem, PA 18015 |
| Contact | Sam Niedbala |
| Correspondent | Sam Niedbala SOLARCARE TECHNOLOGIES CORP,INC. BEN FRANKLIN TECHNOLOGY CENTER 115 RESEARCH DRIVE Bethlehem, PA 18015 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-18 |
| Decision Date | 1992-08-20 |