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
K843343Substantially Equivalent

Medica Iif-Anti-Thyroid Antibody Test

Medical Diagnostics, Ca., Calsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843343 is the FDA 510(k) clearance record for MEDICA IIF-ANTI-THYROID ANTIBODY TEST, a class II device, cleared for Medical Diagnostics, Ca. on under FDA product code JZO (System, Test, Thyroid Autoantibody). FDA records list 4 510(k) clearances for Medical Diagnostics, Ca., from to . As of , FDA records show no recalls naming K843343.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JZO System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
Device class
Class II
Review panel
Immunology
Applicant
Medical Diagnostics, Ca. 2382 Camino Vida Roble, Calsbad CA
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