510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050576Substantially Equivalent

Microalbumin Tia Reagent; Malb Calibrator Set 200; Malb Control-L, Control-H

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

K050576 is the FDA 510(k) clearance record for MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H, a class II device, cleared for Good Biotech Corp. on under FDA product code DDZ (Albumin, Fitc, Antigen, Antiserum, Control). FDA records list 8 510(k) clearances for Good Biotech Corp., from to . As of , FDA records show no recalls naming K050576.

Clearance record

Decision date
Received
(45 days to decision)
Product code
DDZ Albumin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5040
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 DDZ

Trailing 12 months

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

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