Cleared Traditional

BD VIPER INSTRUMENT

K023955 · Becton, Dickinson & CO · Microbiology
Jun 2003
Decision
209d
Days
Class 1
Risk

About This 510(k) Submission

K023955 is an FDA 510(k) clearance for the BD VIPER INSTRUMENT, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on June 24, 2003, 209 days after receiving the submission on November 27, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K023955 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2002
Decision Date June 24, 2003
Days to Decision 209 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750

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