Cleared Traditional

ALKALINE PEPTONE WATER

K871640 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
May 1987
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K871640 is an FDA 510(k) clearance for the ALKALINE PEPTONE WATER, a Culture Media, Selective Broth (Class I — General Controls, product code JSD), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 13, 1987, 16 days after receiving the submission on April 27, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K871640 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1987
Decision Date May 13, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSD — Culture Media, Selective Broth
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360

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