510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252424Substantially Equivalent

Anti-HCV Next

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

K252424 is the FDA 510(k) clearance record for Anti-HCV Next, a class II device, cleared for Abbott Laboratories on under FDA product code MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K252424.

Clearance record

Decision date
Received
(270 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