510(k) K152526
K152526 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Progesterone III CalSet". The FDA issued a decision of Substantially Equivalent on October 2, 2015. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2015
- Date Received
- September 3, 2015
- Clearance Type
- Traditional
- 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