510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153223Substantially Equivalent

ProParaFlu+ Assay

Hologic, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153223 is the FDA 510(k) clearance record for ProParaFlu+ Assay, a class II device, cleared for Hologic, Inc. on under FDA product code OOU (Parainfluenza Multiplex Nucleic Acid Assay). FDA's definition for product code OOU reads: "A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4...". FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K153223.

Clearance record

Decision date
Received
(33 days to decision)
Product code
OOU Parainfluenza Multiplex Nucleic Acid Assay
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Hologic, Inc. 10210 Genetic Center Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOU

Trailing 12 months

FDA records hold no clearances under product code OOU in the trailing twelve months.

FDA records show no clearances under product code OOU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OOU, 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