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510(k) K221817

ALFIS Vitamin D, ALFIS-3 Analyzer by Immunostics Inc., — Product Code MRG

K221817 is an FDA 510(k) premarket notification submitted by Immunostics Inc., for the device "ALFIS Vitamin D, ALFIS-3 Analyzer". The FDA issued a decision of Substantially Equivalent on September 22, 2023. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. Immunostics Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2023
Date Received
June 22, 2022
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 Immunostics Inc.,

  • K182298 — hemochroma PLUS System (November 16, 2018)
  • K163465 — hemochroma PLUS System (September 8, 2017)
  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K060463 — HEMA SCREEN SPECIFIC IFOBT (June 6, 2006)
  • K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (August 11, 2004)
  • K031490 — RUBELLACOL (July 16, 2003)
  • K992759 — COLON ALERT TEST (December 6, 1999)

Other clearances for product code MRG

  • K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay ana (April 12, 2024)
  • 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)
  • K162754 — FREND Vitamin D Test System (January 12, 2017)

FDA data resources