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FDA 510(k)

FASCOUNT SYSTME

K-Number: K933486 · 1994-09-09

ApplicantBecton Dickinson Immunocytometry Systems
Decision Date1994-09-09
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FASCOUNT SYSTME is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Immunocytometry Systems. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K933486. 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 FASCOUNT SYSTME?

FASCOUNT SYSTME is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Becton Dickinson Immunocytometry Systems. The 510(k) number is K933486.

When did FASCOUNT SYSTME receive FDA 510(k) clearance?

FASCOUNT SYSTME received FDA 510(k) clearance on 1994-09-09, under 510(k) number K933486.

Who is the listed applicant for FASCOUNT SYSTME?

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

What is the FDA product code for FASCOUNT SYSTME?

The FDA product code for FASCOUNT SYSTME is GKZ.

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Related Devices (Code: 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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