510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980798Substantially Equivalent

Biosign H. Pylori Wb-New One-Step Anti-H. Pylori Antibody Test

Princeton BioMeditech Corp., Monmouth Junction NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980798 is the FDA 510(k) clearance record for BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST, a class I device, cleared for Princeton BioMeditech Corp. on under FDA product code LYR (Helicobacter Pylori). FDA records list 72 510(k) clearances for Princeton BioMeditech Corp., from to . As of , FDA records show one recall naming K980798.

Clearance record

Decision date
Received
(204 days to decision)
Product code
LYR Helicobacter Pylori
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Princeton BioMeditech Corp. 4242 U.S. Rt. 1, Monmouth Junction NJ
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