510(k) K143680
K143680 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Centaur IgE Master Curve Material". The FDA issued a decision of Substantially Equivalent on January 27, 2015. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2015
- Date Received
- December 24, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type