510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132726Substantially Equivalent

Iceplex C. Difficile Assay Kit, Iceplex System

Primeradx, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132726 is the FDA 510(k) clearance record for ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM, a class II device, cleared for Primeradx on under FDA product code OZN (C. Difficile Toxin Gene Amplification Assay). FDA's definition for product code OZN reads: "Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients". FDA records list one 510(k) clearance for Primeradx. As of , FDA records show no recalls naming K132726.

Clearance record

Decision date
Received
(91 days to decision)
Product code
OZN C. Difficile Toxin Gene Amplification Assay
Regulation
21 CFR 866.3130
Device class
Class II
Review panel
Microbiology
Applicant
Primeradx 171 Forbes Blvd., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZN

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