The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Micro-plate Opiates Assay.
| Device ID | K924446 |
| 510k Number | K924446 |
| Device Name: | MICRO-PLATE OPIATES ASSAY |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-01 |
| Decision Date | 1992-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337000696 | K924446 | 000 |
| 00608337000689 | K924446 | 000 |