510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905643Substantially Equivalent

Bed Red D-Dimer Whole Blood Agglutination Assay

Agen Biomedical, Ltd., Brisbane, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905643 is the FDA 510(k) clearance record for BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY, a class II device, cleared for Agen Biomedical , Ltd. on under FDA product code GHH (Fibrin Split Products). FDA records list 6 510(k) clearances for Agen Biomedical , Ltd., from to . As of , FDA records show one recall naming K905643.

Clearance record

Decision date
Received
(116 days to decision)
Product code
GHH Fibrin Split Products
Regulation
21 CFR 864.7320
Device class
Class II
Review panel
Hematology
Applicant
Agen Biomedical , Ltd. 11 Durbell St., Acacia Ridge, Brisbane, AU
Third party review
No

Clearances, product code GHH

Trailing 12 months

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

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