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510(k) K162754

FREND Vitamin D Test System by Nanoentek USA, Inc. — Product Code MRG

K162754 is an FDA 510(k) premarket notification submitted by Nanoentek USA, Inc. for the device "FREND Vitamin D Test System". The FDA issued a decision of Substantially Equivalent on January 12, 2017. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Nanoentek USA, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2017
Date Received
September 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Vitamin D
Device Class
Class II
Regulation Number
862.1825
Review Panel
CH
Submission Type

Other clearances by Nanoentek USA, Inc.

  • K162378 — FREND PSA PLUS (reagent cartridge) (May 17, 2017)
  • 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 MRG

  • K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay ana (April 12, 2024)
  • K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer (September 22, 2023)
  • K223503 — Access 25(OH) Vitamin D Total (January 19, 2023)
  • K210901 — Elecsys Vitamin D total III (September 1, 2021)
  • K200509 — ADVIA Centaur Vitamin D Total (VitD) (May 29, 2020)
  • K191499 — MAGLUMI 2000 25-OH Vitamin D (August 1, 2019)
  • K180577 — BioPlex 2200 25-OH Vitamin D Kit (June 22, 2018)
  • K172992 — Diazyme EZ Vitamin D Assay (January 11, 2018)
  • K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL (March 16, 2017)
  • K162840 — Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D to (February 8, 2017)

FDA data resources