PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 — Mitsubishi Chemical Medience CO (510(k) K100130)
PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 — Mitsubishi Chemical Medience CO (510(k) K100130) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2; Applicant: Mitsubishi Chemi
| Device name | PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2 |
|---|---|
| Applicant | Mitsubishi Chemical Medience CO |
| Clearance track | 510(k) |
| Submission number | K100130 |
| Decision | Substantially Equivalent |
| Decision date | 2011-05-16 |
| Date received | 2010-01-19 |
| Product code | MMI |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | MD, US |
| Source | openFDA device |
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