510(k) K010588
K010588 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYSCA 15-3 II ASSAY". The FDA issued a decision of Substantially Equivalent on March 28, 2001. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2001
- Date Received
- February 27, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Immunological, Antigen, Tumor
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type