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510(k) K153661

ImmunoCard STAT! HpSA by Meridian Bioscience, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2016
Date Received
December 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Meridian Bioscience, Inc.

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  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K222779 — Revogene (January 26, 2023)
  • K220480 — Revogene (July 11, 2022)
  • K210976 — Curian Campy (December 23, 2021)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (November 30, 2018)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K163273 — TRU Legionella (February 21, 2017)

Other clearances for product code LYR

  • K232892 — Hp Detect™ Stool Antigen ELISA (December 15, 2023)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • K183573 — Vstrip H. pylori Antigen Rapid Test (March 14, 2019)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K151935 — Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whol (August 12, 2015)