510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K262156Substantially Equivalent

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Abbott Laboratories, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(89 days to decision)
Product code
MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Regulation
21 CFR 866.3169
Device class
Class II
Review panel
Microbiology
Applicant
Abbott Laboratories 100 Abbott Park Rd., Abbott Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MZO

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