Cleared Traditional

K904795 - FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
(FDA 510(k) Clearance)

K904795 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device

Dec 1990

Decision

73d

Days

Class 1

Risk

K904795 is an FDA 510(k) clearance for the FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM. This device is classified as a Apparatus, Automated Blood Cell Diluting (Class I - General Controls, product code GKH).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 31, 1990, 73 days after receiving the submission on October 19, 1990.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5240.

Submission Details

510(k) Number	K904795 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 19, 1990
Decision Date	December 31, 1990
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—