The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Amphetamine-specific Intercept Micro-plate Eia, Model 1103i.
| Device ID | K992918 |
| 510k Number | K992918 |
| Device Name: | STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Contact | R. Sam Niedbala |
| Correspondent | R. Sam Niedbala ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem, PA 18018 -1799 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-30 |
| Decision Date | 2000-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337000153 | K992918 | 000 |
| 00608337000146 | K992918 | 000 |