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510(k) K262156

Device
Anti-HCV Next
Applicant
Abbott Laboratories
510(k) number
K262156
Product code
MZO
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-23
Date received
2026-06-26
Regulation
866.3169
Classification name
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Caroline Mendes
Address
100 Abbott Park Rd. Cp1 Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MZO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252424Anti-HCV NextAbbott Laboratories2026-04-28
K221693Elecsys Anti-HCV II (08837031190)Roche Diagnostics2023-01-04