CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN— 510(k) K051925
Substantially EquivalentAccess Bio Incorporate
FDA 510(k) clearance K051925 for CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN, Substantially Equivalent on 2005-11-29. Applicant: Access Bio Incorporate.
Clearance details
- Applicant
- Access Bio Incorporate
- Product code
- Code MMI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monmouth Jct., NJ, 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.