Cleared Traditional

VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE)

K972404 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Pathology
Jul 1997
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K972404 is an FDA 510(k) clearance for the VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE), a Flask, Tissue Culture (Class I — General Controls, product code KJA), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 22, 1997, 26 days after receiving the submission on June 26, 1997. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K972404 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1997
Decision Date July 22, 1997
Days to Decision 26 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code KJA — Flask, Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240