510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233352Substantially Equivalent

Aptima HCV Quant Dx Assay

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

K233352 is the FDA 510(k) clearance record for Aptima HCV Quant Dx Assay, a class II device, cleared for Hologic, Inc. on under FDA product code MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K233352.

Clearance record

Decision date
Received
(299 days to decision)
Product code
MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Regulation
21 CFR 866.3170
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 MZP

Trailing 12 months
1 clearance under product code MZP 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 MZP, 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