The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Nat. Screening Institute Micro-plate Free T4 Assay.
| Device ID | K925649 |
| 510k Number | K925649 |
| Device Name: | NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY |
| Classification | Radioimmunoassay, Free Thyroxine |
| 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 | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1993-03-01 |