510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020348Substantially Equivalent

Abbott Axsym Anti-Thyroid-Peroxidase, Models5f57 Comprising Standards/calibrators

Axis-Shield Diagnostics, Ltd., Dundee, Scotland, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020348 is the FDA 510(k) clearance record for ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS, a class II device, cleared for Axis-Shield Diagnostics, Ltd. on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 28 510(k) clearances for Axis-Shield Diagnostics, Ltd., from to . As of , FDA records show no recalls naming K020348.

Clearance record

Decision date
Received
(87 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Axis-Shield Diagnostics, Ltd. The Technology Park, Dundee, Scotland, GB
510(k) summary
Statement
Third party review
No

Clearances, product code JZO

Trailing 12 months

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

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