510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242492Substantially Equivalent

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

Techno-Path Manufacturing Ltd., Co. Tipperary, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242492 is the FDA 510(k) clearance record for Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN), a class II device, cleared for Techno-Path Manufacturing , Ltd. on under FDA product code QCH (Assayed Quality Control Material For Clinical Microbiology Assays). FDA's definition for product code QCH reads: "Serologic controls for microbiology assays". FDA records list 7 510(k) clearances for Techno-Path Manufacturing , Ltd., from to . As of , FDA records show no recalls naming K242492.

Clearance record

Decision date
Received
(496 days to decision)
Product code
QCH Assayed Quality Control Material For Clinical Microbiology Assays
Regulation
21 CFR 866.3920
Device class
Class II
Review panel
Microbiology
Applicant
Techno-Path Manufacturing , Ltd. Fort Henry Business Park,, Co. Tipperary, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QCH

Trailing 12 months
1 clearance under product code QCH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QCH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260