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510(k) K934863

FLEXSURE HP by Smithkline Diagnostics, Inc. — Product Code LYR

K934863 is an FDA 510(k) premarket notification submitted by Smithkline Diagnostics, Inc. for the device "FLEXSURE HP". The FDA issued a decision of Substantially Equivalent on May 18, 1994. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Smithkline Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1994
Date Received
October 12, 1993
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 Smithkline Diagnostics, Inc.

  • K961062 — FLEXSURE OBT (November 6, 1996)
  • K960183 — FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS F (June 7, 1996)
  • K880499 — HEMOCCULT SENSITIVE TEST (May 23, 1988)
  • K875131 — (SKD) CHOLESTEROL TEST KIT (March 1, 1988)
  • K862849 — HEMOCCULT WIPE TEST (December 9, 1986)
  • K854723 — SKD ELECTROCHEMICAL SYSTEM (ECS) (March 5, 1986)
  • K852841 — RAPID DIRECT STREP A LATEX AGGLUTINATION TEST (July 24, 1985)
  • K821884 — GASTROCCULT TM (October 8, 1982)
  • K821674 — SPINCHEM ACID PHOSPHATASE REAGENT (June 22, 1982)
  • K821184 — SPIN CHEM REAGENTS & STANDARDS (May 24, 1982)

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