The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for National Screening Institute Micro-plate Tsh Assay.
| Device ID | K923532 |
| 510k Number | K923532 |
| Device Name: | NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| 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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1993-03-12 |