510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K041238Substantially Equivalent

Helicobacter Pylori Igg Elisa

Biohit PLC, Neptune NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041238 is the FDA 510(k) clearance record for HELICOBACTER PYLORI IGG ELISA, a class I device, cleared for Biohit Plc on under FDA product code LYR (Helicobacter Pylori). FDA records list one 510(k) clearance for Biohit Plc. As of , FDA records show no recalls naming K041238.

Clearance record

Decision date
Received
(216 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Biohit Plc 3535 Rte. 66, Neptune NJ
510(k) summary
Summary PDF
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