The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Precicontrol Troponin T.
| Device ID | K031990 |
| 510k Number | K031990 |
| Device Name: | ELECSYS PRECICONTROL TROPONIN T |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Theresa M Ambrose |
| Correspondent | Theresa M Ambrose ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2003-08-20 |
| Summary: | summary |