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510(k) K232892

Hp Detect™ Stool Antigen ELISA by Biomerica, Inc. — Product Code LYR

K232892 is an FDA 510(k) premarket notification submitted by Biomerica, Inc. for the device "Hp Detect™ Stool Antigen ELISA". The FDA issued a decision of Substantially Equivalent on December 15, 2023. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Biomerica, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2023
Date Received
September 18, 2023
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 Biomerica, Inc.

  • K003856 — EZ-HCG URINE(PREGNANCY TEST) (February 21, 2001)
  • K982954 — FREE T4 MICROWELL EIA, MODEL #7019 (September 24, 1998)
  • K962216 — TSH (MICROWELL) ELISA (September 19, 1996)
  • K960412 — T-3 MICROWELL EIA MODEL 7013 (March 19, 1996)
  • K954256 — ANTI-TPO (November 27, 1995)
  • K950588 — T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 (June 29, 1995)
  • K936010 — THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (July 18, 1994)
  • K915185 — GAP IGG H.PYLORI MODIFIED (March 4, 1992)
  • K900343 — GAP-IGG (August 22, 1991)

Other clearances for product code LYR

  • 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)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
  • K153661 — ImmunoCard STAT! HpSA (March 14, 2016)
  • K151935 — Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whol (August 12, 2015)

FDA data resources