Cleared Traditional

BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM

K865021 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Feb 1987
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K865021 is an FDA 510(k) clearance for the BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM, 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 February 6, 1987, 45 days after receiving the submission on December 23, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K865021 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1986
Decision Date February 06, 1987
Days to Decision 45 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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