The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Architect Stat Ck-mb Immunoassay.
| Device ID | K041596 |
| 510k Number | K041596 |
| Device Name: | ARCHITECT STAT CK-MB IMMUNOASSAY |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| 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 | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-07-21 |
| Summary: | summary |