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FDA 510(k)

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER

K-Number: K913305 · 1991-11-22

ApplicantUnipath , Ltd.
Decision Date1991-11-22
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K913305. 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 CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER?

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Unipath , Ltd.. The 510(k) number is K913305.

When did CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER receive FDA 510(k) clearance?

CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER received FDA 510(k) clearance on 1991-11-22, under 510(k) number K913305.

Who is the listed applicant for CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER?

The FDA 510(k) record lists Unipath , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER?

The FDA product code for CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER is GKZ.

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Related Devices (Code: GKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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