510(k) K162378
K162378 is an FDA 510(k) premarket notification submitted by Nanoentek USA, Inc. for the device "FREND PSA PLUS (reagent cartridge)". The FDA issued a decision of Substantially Equivalent on May 17, 2017. The device falls under product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers), a Class II device regulated under 21 CFR 866.6010. Nanoentek USA, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2017
- Date Received
- August 24, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type