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FDA 510(k)

FACSTRAK FLOW CYTOMETER

K-Number: K914014 · 1991-12-04

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1991-12-04
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACSTRAK FLOW CYTOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1991-12-04 under 510(k) number K914014. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FACSTRAK FLOW CYTOMETER?

FACSTRAK FLOW CYTOMETER is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K914014.

When did FACSTRAK FLOW CYTOMETER receive FDA 510(k) clearance?

FACSTRAK FLOW CYTOMETER received FDA 510(k) clearance on 1991-12-04, under 510(k) number K914014.

Who is the listed applicant for FACSTRAK FLOW CYTOMETER?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACSTRAK FLOW CYTOMETER?

The FDA product code for FACSTRAK FLOW CYTOMETER is GKZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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