510(k) K112142
K112142 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on November 4, 2011. The device falls under product code NDW (Assay, Porphyrin, Spectrophotometry, Lithium), a Class II device regulated under 21 CFR 862.3560. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2011
- Date Received
- July 26, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Porphyrin, Spectrophotometry, Lithium
- Device Class
- Class II
- Regulation Number
- 862.3560
- Review Panel
- TX
- Submission Type