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510(k) K181400

H. PYLORI CHEK™ by Techlab, Inc. — Product Code LYR

K181400 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "H. PYLORI CHEK™". The FDA issued a decision of Substantially Equivalent on August 21, 2018. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Techlab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2018
Date Received
May 29, 2018
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 Techlab, Inc.

  • K191456 — Campylobacter Quik Chek (June 20, 2019)
  • K191442 — Campylobacter Chek (June 20, 2019)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)
  • K051927 — TECHLAB ASCA-CHEK (April 6, 2006)

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)
  • 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