TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM — Bayer Healthcare, LLC (510(k) K052503)
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM — Bayer Healthcare, LLC (510(k) K052503) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM; Applicant: Bayer Healthcare, LLC; Clearance track: 510(k).
| Device name | TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM |
|---|---|
| Applicant | Bayer Healthcare, LLC |
| Clearance track | 510(k) |
| Submission number | K052503 |
| Decision | Substantially Equivalent |
| Decision date | 2005-12-14 |
| Date received | 2005-09-13 |
| Product code | MMI |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | NY, US |
| Source | openFDA device |
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