510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K151935Substantially Equivalent

Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only

Alere San Diego, Incorporated, San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151935 is the FDA 510(k) clearance record for Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only, a class I device, cleared for Alere San Diego, Incorporated on under FDA product code LYR (Helicobacter Pylori). FDA records list one 510(k) clearance for Alere San Diego, Incorporated. As of , FDA records show no recalls naming K151935.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Alere San Diego, Incorporated 9975 Summers Ridge Rd., San Diego CA
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