The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Solarcare Technologies Corp. Micro-plate Pcp Assay.
| Device ID | K924751 |
| 510k Number | K924751 |
| Device Name: | SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | Sam Niedbala |
| Correspondent | Sam Niedbala SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-23 |
| Decision Date | 1992-12-11 |