URINE CULTURE KIT— 510(k) K790366

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code JTW

Device class

Class 1

Regulation

21 CFR 866.2900

Advisory panel

Microbiology

Date received

1979-02-22

Decision date

1979-04-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Washington, DC, US

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• Z-0491-2019 — BD Vacutainer Urine Collection Cups, Cat. No. 364941Class II·Terminated·Becton Dickinson & Company·20180830

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K790366.