The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Loci Cardiac Troponin I Calibrator, Model Rc621.
| Device ID | K081683 |
| 510k Number | K081683 |
| Device Name: | LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 |
| Classification | Calibrator, Secondary |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768022074 | K081683 | 000 |