Home / 510(k) Clearances / K123983

510(k) K123983

FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS by Qualigen, Inc. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2013
Date Received
December 26, 2012
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 Qualigen, Inc.

  • K182521 — FastPack IP Sex Hormone Binding Globulin Immunoassay (January 29, 2019)
  • K141689 — FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Rea (January 7, 2015)
  • K123725 — FASTPACK CONTROL KIT (March 8, 2013)
  • K101388 — FASTPACK TESTO IMMUNOASSAY (February 18, 2011)
  • K101390 — FASTPACK TSH IMMUNOASSAY (August 13, 2010)
  • K072264 — FASTPACK HCG IMMUNOASSAY (December 6, 2007)
  • K062957 — FASTPACK TOTAL PSA METHOD VERIFICATION KIT (April 2, 2007)
  • K052301 — FASTPACK TSH IMMUNOASSAY (January 4, 2006)
  • K030329 — FASTPACK FREE T4 IMMUNOASSAY (July 3, 2003)
  • K022533 — FASTPACK TESTOSTERONE CALIBRATOR (September 30, 2002)

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)