The following data is part of a premarket notification filed by Solarcare, Inc. with the FDA for Stc Cocaine Metabolite Eia.
| Device ID | K934775 |
| 510k Number | K934775 |
| Device Name: | STC COCAINE METABOLITE EIA |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | SOLARCARE, INC. 115 RESEARCH DR. Bethlehem, PA 18015 |
| Contact | R. Sam Niedbala |
| Correspondent | R. Sam Niedbala SOLARCARE, INC. 115 RESEARCH DR. Bethlehem, PA 18015 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-05 |
| Decision Date | 1995-07-14 |