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FDA 510(k)

AUTOLYZER 800

K-Number: K841852 · 1984-09-05

ApplicantGeometric Data, Div. Smithkline Corp.
Decision Date1984-09-05
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOLYZER 800 is the device name listed in this FDA 510(k) record. The listed applicant is Geometric Data, Div. Smithkline Corp.. It received FDA 510(k) clearance on 1984-09-05 under 510(k) number K841852. 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 AUTOLYZER 800?

AUTOLYZER 800 is a medical device that received FDA 510(k) clearance on 1984-09-05. The listed applicant is Geometric Data, Div. Smithkline Corp.. The 510(k) number is K841852.

When did AUTOLYZER 800 receive FDA 510(k) clearance?

AUTOLYZER 800 received FDA 510(k) clearance on 1984-09-05, under 510(k) number K841852.

Who is the listed applicant for AUTOLYZER 800?

The FDA 510(k) record lists Geometric Data, Div. Smithkline Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOLYZER 800?

The FDA product code for AUTOLYZER 800 is GKZ.

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Other records listing Geometric Data, Div. Smithkline Corp. 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.

K811534HEMASPINNERK791041HEMATRAK ABNORMAL RECOGNITIONK791108CONTEXT FILTERK790816HEMATRAK MODEL 480K790042STAIN, HEMASTAIN RETICK780577PLATELETS/CU MM

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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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