510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905049Substantially Equivalent

Quidel Helicobacter Pylori Postive/negative Contr

Ortho-Clinical Diagnostics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905049 is the FDA 510(k) clearance record for QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR, a class I device, cleared for Quidel Corp. on under FDA product code LYR (Helicobacter Pylori). FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming K905049.

Clearance record

Decision date
Received
(180 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Quidel Corp. 10165 Mckellar Ct., San Diego CA
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