510(k) K160863
K160863 is an FDA 510(k) premarket notification submitted by Kitazato Biopharma Co., Ltd. for the device "PBS(-), Phosphate Buffered Saline". The FDA issued a decision of Substantially Equivalent on Jul 28, 2016. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Kitazato Biopharma Co., Ltd. has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 2016
- Date Received
- Mar 29, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type
- 510(k)