510(k) K160113
K160113 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "ST AIA-PACK hsE2 Calibrator Set". The FDA issued a decision of Substantially Equivalent on February 17, 2016. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Tosoh Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2016
- Date Received
- January 19, 2016
- 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