LEUCOPREP CELL SEPARATION TUBE— 510(k) K891407

Clearance details

Applicant

Bd Becton Dickinson Vacutainer Systems Preanalytic

Product code

Code JCF

Device class

Class 1

Regulation

21 CFR 864.8500

Advisory panel

Hematology

Date received

1989-03-14

Decision date

1989-05-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Franklin Lakes, NJ, US

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• Z-2542-2014 — BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.Class II·Terminated·Becton Dickinson & Company·20140703

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K891407.