Cleared Traditional

K853534 - BBL CAMPY POUCH
(FDA 510(k) Clearance)

K853534 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology

Aug 1985

Decision

Days

Class 1

Risk

K853534 is an FDA 510(k) clearance for the BBL CAMPY POUCH, a Device, Gas Generating (Class I — General Controls, product code KZJ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on August 29, 1985, 6 days after receiving the submission on August 23, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2580.

Submission Details

510(k) Number	K853534 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 1985
Decision Date	August 29, 1985
Days to Decision	6 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—