510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984228Substantially Equivalent

Is Anti-Tpo Igg Elisa Test System

Columbia Bioscience, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984228 is the FDA 510(k) clearance record for IS ANTI-TPO IGG ELISA TEST SYSTEM, a class II device, cleared for Columbia Bioscience, Inc. on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 13 510(k) clearances for Columbia Bioscience, Inc., from to . As of , FDA records show no recalls naming K984228.

Clearance record

Decision date
Received
(69 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Columbia Bioscience, Inc. 8775 M Centre Park Dr., Columbia MD
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