510(k) K093939
K093939 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "ADVIA CHEMISTRY SALICYLATE REAGENT". The FDA issued a decision of Substantially Equivalent on May 19, 2010. The device falls under product code DKJ (Colorimetry, Salicylate), a Class II device regulated under 21 CFR 862.3830. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2010
- Date Received
- December 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetry, Salicylate
- Device Class
- Class II
- Regulation Number
- 862.3830
- Review Panel
- TX
- Submission Type