The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Troponin I Calcheck 5.
| Device ID | K100594 |
| 510k Number | K100594 |
| Device Name: | ELECSYS TROPONIN I CALCHECK 5 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD PO BOX 50410 Indianapolis, IN 46250 |
| Contact | Sarah Baumann |
| Correspondent | Sarah Baumann Roche Diagnostics 9115 HAGUE ROAD PO BOX 50410 Indianapolis, IN 46250 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-04-01 |
| Summary: | summary |