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
K904822Substantially Equivalent

Elegance Ferritin Elisa

Bioclone Australia Pty, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904822 is the FDA 510(k) clearance record for ELEGANCE FERRITIN ELISA, a class II device, cleared for Bioclone Australia Pty , Ltd. on under FDA product code DBF (Ferritin, Antigen, Antiserum, Control). FDA records list 10 510(k) clearances for Bioclone Australia Pty , Ltd., from to . As of , FDA records show no recalls naming K904822.

Clearance record

Decision date
Received
(36 days to decision)
Product code
DBF Ferritin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5340
Device class
Class II
Review panel
Immunology
Applicant
Bioclone Australia Pty , Ltd. C/O Mackler & Gibbs, P.C., Washington DC
Third party review
No

Clearances, product code DBF

Trailing 12 months

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

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