The following data is part of a premarket notification filed by Solarcare, Inc. with the FDA for Stc Diagnostic Auto-lyte Propoxyphene Eia.
| Device ID | K944372 |
| 510k Number | K944372 |
| Device Name: | STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA |
| Classification | Enzyme Immunoassay, Propoxyphene |
| 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 | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-07 |
| Decision Date | 1995-02-08 |