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
K052617Substantially Equivalent

Ferritin Lit Assay, Catalog No. 7010; Ferritin Calibrator Set, Catalog No. 7510; Ferritin Controls, Level-L & Level-H,

Good Biotech Corp., Taichung, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052617 is the FDA 510(k) clearance record for FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,, a class II device, cleared for Good Biotech Corp. on under FDA product code DBF (Ferritin, Antigen, Antiserum, Control). FDA records list 8 510(k) clearances for Good Biotech Corp., from to . As of , FDA records show no recalls naming K052617.

Clearance record

Decision date
Received
(153 days to decision)
Product code
DBF Ferritin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5340
Device class
Class II
Review panel
Immunology
Applicant
Good Biotech Corp. 38, 34th Rd., Taichung, TW
510(k) summary
Summary PDF
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