FREND PSA PLUS (reagent cartridge)
K-Number: K162378 · 2017-05-17
ApplicantNanoentek USA, Inc.
Decision Date2017-05-17
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
FREND PSA PLUS (reagent cartridge) is a medical device manufactured by Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2017-05-17 under approval number K162378. The device is classified under product code LTJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FREND PSA PLUS (reagent cartridge)?
FREND PSA PLUS (reagent cartridge) is a medical device that received FDA 510(k) clearance on 2017-05-17. It is manufactured by Nanoentek USA, Inc.. The 510(k) number is K162378.
When was FREND PSA PLUS (reagent cartridge) approved by the FDA?
FREND PSA PLUS (reagent cartridge) received FDA 510(k) clearance on 2017-05-17, under approval number K162378.
What company makes FREND PSA PLUS (reagent cartridge)?
FREND PSA PLUS (reagent cartridge) is manufactured by Nanoentek USA, Inc..
What is the FDA product code for FREND PSA PLUS (reagent cartridge)?
The FDA product code for FREND PSA PLUS (reagent cartridge) is LTJ.
Other Devices by Nanoentek USA, Inc.
Related Devices (Code: LTJ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.