Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GENESIS I AUTOMATED CELL COUNTER

K-Number: K910679 · 1991-05-07

ApplicantAlicia Diagnostics, Inc.
Decision Date1991-05-07
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GENESIS I AUTOMATED CELL COUNTER 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 1991-05-07 under 510(k) number K910679. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS I AUTOMATED CELL COUNTER?

GENESIS I AUTOMATED CELL COUNTER is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is Alicia Diagnostics, Inc.. The 510(k) number is K910679.

When did GENESIS I AUTOMATED CELL COUNTER receive FDA 510(k) clearance?

GENESIS I AUTOMATED CELL COUNTER received FDA 510(k) clearance on 1991-05-07, under 510(k) number K910679.

Who is the listed applicant for GENESIS I AUTOMATED CELL COUNTER?

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 I AUTOMATED CELL COUNTER?

The FDA product code for GENESIS I AUTOMATED CELL COUNTER is GKL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K925909GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION

Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex America, Inc.

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.

↑