LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L— 510(k) K121084
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K121084 for LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L, Substantially Equivalent on 2012-05-09. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Newark, DE, US
Recent devices under product code JJX
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allAdverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.