510(k) K132400
K132400 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "LP(A) CALIBRATORS, AND LP(A) CONTROLS". The FDA issued a decision of Substantially Equivalent on December 19, 2013. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Biokit, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2013
- Date Received
- August 1, 2013
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Secondary
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type