510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K912255Substantially Equivalent

Hycor Pyloragen Helicobacter Pylori Test

Hycor Biomedical, Garden Grove CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912255 is the FDA 510(k) clearance record for HYCOR PYLORAGEN HELICOBACTER PYLORI TEST, a class I device, cleared for Hycor Biomedical, Inc. on under FDA product code LYR (Helicobacter Pylori). FDA records list 66 510(k) clearances for Hycor Biomedical, Inc., from to . As of , FDA records show no recalls naming K912255.

Clearance record

Decision date
Received
(142 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Hycor Biomedical, Inc. 7272 Chapman Ave., Garden Grove CA
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYR, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260