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FDA 510(k)

CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER

K-Number: K854368 · 1986-01-01

ApplicantAbbott Diagnostics
Decision Date1986-01-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1986-01-01 under 510(k) number K854368. 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 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER?

CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1986-01-01. The listed applicant is Abbott Diagnostics. The 510(k) number is K854368.

When did CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1986-01-01, under 510(k) number K854368.

Who is the listed applicant for CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER?

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

What is the FDA product code for CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER?

The FDA product code for CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER is GKZ.

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Other records listing Abbott Diagnostics 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.

K964185IMX CA 125K972182ABBOTT STREP A CONTROLSK961439ABBOTT CELL-DYN 4000 SYSTEMK890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYERK881242CELL-DYN RAPID-LYSE AND HEMOGLOBLINK881130CELL-DYN ISOTONIC DILUENT

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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.

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

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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