Cleared Traditional

BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS

K024240 · Bd · Microbiology
Mar 2003
Decision
93d
Days
Class 1
Risk

About This 510(k) Submission

K024240 is an FDA 510(k) clearance for the BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on March 26, 2003, 93 days after receiving the submission on December 23, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K024240 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2002
Decision Date March 26, 2003
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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