The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Opiates Micro-plate Assay.
| Device ID | K935565 |
| 510k Number | K935565 |
| Device Name: | OPIATES MICRO-PLATE ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R. Sam Niedbala, Ph.d. |
| Correspondent | R. Sam Niedbala, Ph.d. SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1995-07-14 |