PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2— 510(k) K100130
Substantially EquivalentMitsubishi Chemical Medience CO
FDA 510(k) clearance K100130 for PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2, Substantially Equivalent on 2011-05-16. Applicant: Mitsubishi Chemical Medience CO.
Clearance details
- Applicant
- Mitsubishi Chemical Medience CO
- Product code
- Code MMI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baldwin, MD, US
Adverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.