IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material— 510(k) K143504
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K143504 for IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material, Substantially Equivalent on 2015-01-14. Applicant: Siemens Healthcare Diagnostics, Inc..
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Adverse 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.