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FDA 510(k)

CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER

K-Number: K870233 · 1987-03-17

ApplicantAbbott Diagnostics
Decision Date1987-03-17
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. 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 1987-03-17 under 510(k) number K870233. 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 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER?

CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Abbott Diagnostics. The 510(k) number is K870233.

When did CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER receive FDA 510(k) clearance?

CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER received FDA 510(k) clearance on 1987-03-17, under 510(k) number K870233.

Who is the listed applicant for CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. 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 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER?

The FDA product code for CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. 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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