510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K915428Substantially Equivalent

Kronus Kalibre Thyroglobulin Antibody Eia Kit

Kronus, Inc., Dana Point CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915428 is the FDA 510(k) clearance record for KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT, a class II device, cleared for Kronus on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 9 510(k) clearances for Kronus, from to . As of , FDA records show no recalls naming K915428.

Clearance record

Decision date
Received
(119 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Kronus P.O. Box 1075 Suite 312, Dana Point CA
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