The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Auto-lyte Methadone Dia.
| Device ID | K944056 |
| 510k Number | K944056 |
| Device Name: | AUTO-LYTE METHADONE DIA |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | Sam R Niedbala |
| Correspondent | Sam R Niedbala SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1994-12-29 |