Cleared Traditional

K842279 - BECTEC NR-660 BACTERIAL DETECT SYS
(FDA 510(k) Clearance)

K842279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology

Jul 1984

Decision

42d

Days

Class 1

Risk

K842279 is an FDA 510(k) clearance for the BECTEC NR-660 BACTERIAL DETECT SYS, a Monitor, Microbial Growth (Class I — General Controls, product code JTA), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on July 20, 1984, 42 days after receiving the submission on June 8, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number	K842279 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 1984
Decision Date	July 20, 1984
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—