The following data is part of a premarket notification filed by Solarcare Technologies Corp,inc. with the FDA for Stc Diagnostics Auto-lyte Benzodiazepines Eia.
| Device ID | K934869 |
| 510k Number | K934869 |
| Device Name: | STC DIAGNOSTICS AUTO-LYTE BENZODIAZEPINES EIA |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R S Niedbala, Ph.d |
| Correspondent | R S Niedbala, Ph.d SOLARCARE TECHNOLOGIES CORP,INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1993-11-22 |