BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY— 510(k) K905643

Name: FDA 510(k) clearance K905643
Creator: U.S. Food and Drug Administration
Published: 1991-04-12

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K905643 for BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY, Substantially Equivalent on 1991-04-12. Applicant: Agen Biomedical , Ltd.. Device class: 2.

Clearance details

Applicant: Agen Biomedical , Ltd.
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1990-12-17
Decision date: 1991-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, AU

Download summary PDF View on FDA.gov ↗

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Recalls naming K905643

K-number listed on FDA's recall record

Z-0314-2017 — SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole bloodClass II·Terminated·BBI SOLUTIONS OEM LTD·20160601

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K905643.

Data sourced from openFDA. This site is unofficial and independent of the FDA.