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510(k) K052708

PYLO-PLUS by Arj Medical, Inc. — Product Code LYR

K052708 is an FDA 510(k) premarket notification submitted by Arj Medical, Inc. for the device "PYLO-PLUS". The FDA issued a decision of Substantially Equivalent on May 1, 2006. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Arj Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2006
Date Received
September 29, 2005
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 Arj Medical, Inc.

  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K052719 — URITEST 10 URINALYSIS REAGENT STRIPS (December 5, 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)
  • 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)

FDA data resources