The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Architect Stat Troponin-i Immunoassay.
| Device ID | K041192 |
| 510k Number | K041192 |
| Device Name: | ARCHITECT STAT TROPONIN-I IMMUNOASSAY |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | FISHER DIAGNOSTICS 8365 VALLEY PIKE, PO BX 307 Middletown, VA 22645 |
| Contact | Josefina Infantas |
| Correspondent | Josefina Infantas FISHER DIAGNOSTICS 8365 VALLEY PIKE, PO BX 307 Middletown, VA 22645 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-06 |
| Decision Date | 2004-08-12 |
| Summary: | summary |