510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K182703Substantially Equivalent

EntericBio Dx Assay

Serosep, Ltd., Annacotty, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182703 is the FDA 510(k) clearance record for EntericBio Dx Assay, a class II device, cleared for Serosep , Ltd. on under FDA product code PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System). FDA's definition for product code PCH reads: "A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool...". FDA records list one 510(k) clearance for Serosep , Ltd. As of , FDA records show no recalls naming K182703.

Clearance record

Decision date
Received
(265 days to decision)
Product code
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Regulation
21 CFR 866.3990
Device class
Class II
Review panel
Microbiology
Applicant
Serosep , Ltd. Annacotty Business Park, Annacotty, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCH

Trailing 12 months
3 clearances under product code PCH in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PCH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260