The following data is part of a premarket notification filed by Solarcare, Inc. with the FDA for Stc Diagnostics Auto-lyte Barbiturates Eia.
| Device ID | K934376 |
| 510k Number | K934376 |
| Device Name: | STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-09 |
| Decision Date | 1993-12-07 |