IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL— 510(k) K122534
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K122534 for IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL, Substantially Equivalent on 2013-03-14. 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
- Tarrytown, NY, 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.