510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K920827Substantially Equivalent

Amrad Hel-Ptest

Amrad, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920827 is the FDA 510(k) clearance record for AMRAD HEL-PTEST, a class I device, cleared for Amrad on under FDA product code LYR (Helicobacter Pylori). FDA records list one 510(k) clearance for Amrad. As of , FDA records show no recalls naming K920827.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Amrad Washington Sq., Suite 1100, Washington DC
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 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