510(k) K213510
K213510 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products, Ltd. for the device "IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)), a Class II device regulated under 21 CFR 866.6010. Siemens Healthcare Diagnostics Products, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2023
- Date Received
- November 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type