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FDA 510(k)

GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION

K-Number: K925909 · 1994-10-27

ApplicantAlicia Diagnostics, Inc.
Decision Date1994-10-27
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Alicia Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-10-27 under 510(k) number K925909. 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 GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION?

GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-10-27. The listed applicant is Alicia Diagnostics, Inc.. The 510(k) number is K925909.

When did GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION receive FDA 510(k) clearance?

GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION received FDA 510(k) clearance on 1994-10-27, under 510(k) number K925909.

Who is the listed applicant for GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION?

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

What is the FDA product code for GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION?

The FDA product code for GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION is GKZ.

Related Clinical Trials

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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Other records listing Alicia Diagnostics, Inc. as applicant

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.

K910679GENESIS I AUTOMATED CELL COUNTER

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

Official Source

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

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