Cleared Traditional

BACTEC 170 TRYPTIC SOY BROTH W/RESINS

K830363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology

Mar 1983

Decision

48d

Days

Class 1

Risk

About This 510(k) Submission

K830363 is an FDA 510(k) clearance for the BACTEC 170 TRYPTIC SOY BROTH W/RESINS, a Device, Antimicrobial Drug Removal (Class I — General Controls, product code LJF), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 24, 1983, 48 days after receiving the submission on February 4, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number	K830363 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 1983
Decision Date	March 24, 1983
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—