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510(k) K162378

FREND PSA PLUS (reagent cartridge) by Nanoentek USA, Inc. — Product Code LTJ

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

Other clearances by Nanoentek USA, Inc.

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  • K153577 — FREND Testosterone Test System (October 14, 2016)
  • K152422 — FREND™ Free T4 Test System (February 17, 2016)
  • K131928 — FREND TSH (REAGENT CARTRIDGE) (March 14, 2014)

Other clearances for product code LTJ

  • K251630 — Atellica IM Total PSA II (tPSAII) (January 5, 2026)
  • K124056 — FREND PSA PLUS (REAGENT CARTRIDGE) (May 29, 2013)
  • K031343 — TPSA FLEX REAGENT CARTRIDGE (May 15, 2003)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K010550 — VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (April 24, 2001)
  • K003963 — DIMENSION PSA FLEX REAGENT CARTRIDGE (February 28, 2001)
  • K002376 — ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (October 26, 2000)
  • K003094 — FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (October 25, 2000)
  • K002121 — TOTAL PSA MICROTITER ELISA (August 30, 2000)