The following data is part of a premarket notification filed by Solarcare, Inc. with the FDA for Solarcare Total Protein Micro-plate Assay.
| Device ID | K941496 |
| 510k Number | K941496 |
| Device Name: | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | SOLARCARE, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R. Sam Niedbala |
| Correspondent | R. Sam Niedbala SOLARCARE, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-10-27 |