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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Nanoentek USA, Inc.. It received FDA 510(k) clearance on 2017-05-17 under 510(k) 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. The listed applicant is Nanoentek USA, Inc.. The 510(k) number is K162378.

When did FREND PSA PLUS (reagent cartridge) receive FDA 510(k) clearance?

FREND PSA PLUS (reagent cartridge) received FDA 510(k) clearance on 2017-05-17, under 510(k) number K162378.

Who is the listed applicant for FREND PSA PLUS (reagent cartridge)?

The FDA 510(k) record lists Nanoentek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Nanoentek USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162754FREND Vitamin D Test SystemK153577FREND Testosterone Test SystemK152422FREND™ Free T4 Test System

Related Devices (Code: LTJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P000027PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSRoche Diagnostics Corp.K251630Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc.PMA P000021PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSSiemens Healthcare Diagnostics

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.

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