Cleared Traditional

BBL(R) GASPAK CO2 POUCH(TM)

K872782 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Aug 1987
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K872782 is an FDA 510(k) clearance for the BBL(R) GASPAK CO2 POUCH(TM), a Device, Gas Generating (Class I — General Controls, product code KZJ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 6, 1987, 23 days after receiving the submission on July 14, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2580.

Submission Details

510(k) Number K872782 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1987
Decision Date August 06, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KZJ — Device, Gas Generating
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2580

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