510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003291Substantially Equivalent

Bayer Diagnostics Acs:180 and Advia Centaur Anti-Tpo Assay

Bayer Diagnostics Corp., Medfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003291 is the FDA 510(k) clearance record for BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY, a class II device, cleared for Bayer Diagnostics Corp. on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 32 510(k) clearances for Bayer Diagnostics Corp., from to . As of , FDA records show 2 recalls naming K003291.

Clearance record

Decision date
Received
(46 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Bayer Diagnostics Corp. 63 N. St., Medfield MA
510(k) summary
Summary
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