510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934863Substantially Equivalent

Flexsure Hp

Smithkline Diagnostics, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934863 is the FDA 510(k) clearance record for FLEXSURE HP, a class I device, cleared for Smithkline Diagnostics, Inc. on under FDA product code LYR (Helicobacter Pylori). FDA records list 42 510(k) clearances for Smithkline Diagnostics, Inc., from to . As of , FDA records show no recalls naming K934863.

Clearance record

Decision date
Received
(218 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Smithkline Diagnostics, Inc. 225 Baypointe Pkwy., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code LYR

Trailing 12 months

FDA records hold no clearances under product code LYR in the trailing twelve months.

FDA records show no clearances under product code LYR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260