Cleared Traditional

BACTEC NR-860

K910835 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Mar 1991
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K910835 is an FDA 510(k) clearance for the BACTEC NR-860, a Monitor, Microbial Growth (Class I — General Controls, product code JTA), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 11, 1991, 12 days after receiving the submission on February 27, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K910835 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1991
Decision Date March 11, 1991
Days to Decision 12 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTA — Monitor, Microbial Growth
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

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