VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)— 510(k) K972404

Name: FDA 510(k) clearance K972404
Creator: U.S. Food and Drug Administration
Published: 1997-07-22

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K972404 for VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE), Substantially Equivalent on 1997-07-22. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KJA
Device class: Class 1
Regulation: 21 CFR 864.2240
Advisory panel: Hematology
Date received: 1997-06-26
Decision date: 1997-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lake, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K972404

K-number listed on FDA's recall record

Z-1122-2019 — BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010Class II·Terminated·Becton Dickinson & Company·20190307

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972404.

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