510(k) K091361
K091361 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 2009. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2009
- Date Received
- May 8, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type