510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183223Substantially Equivalent

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

DiaSorin Molecular LLC, Cypress CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183223 is the FDA 510(k) clearance record for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack, a class II device, cleared for Diasorin Molecular, LLC on under FDA product code OZZ (Bordetella Pertussis Dna Assay System). FDA's definition for product code OZZ reads: "A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in...". FDA records list 32 510(k) clearances for Diasorin Molecular, LLC, from to . As of , FDA records show no recalls naming K183223.

Clearance record

Decision date
Received
(29 days to decision)
Product code
OZZ Bordetella Pertussis Dna Assay System
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Diasorin Molecular, LLC 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZZ

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