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FDA 510(k)

MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800

K-Number: K981568 · 1998-08-21

ApplicantCdc Technologies, Inc.
Decision Date1998-08-21
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 is the device name listed in this FDA 510(k) record. The listed applicant is Cdc Technologies, Inc.. It received FDA 510(k) clearance on 1998-08-21 under 510(k) number K981568. 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 MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800?

MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 is a medical device that received FDA 510(k) clearance on 1998-08-21. The listed applicant is Cdc Technologies, Inc.. The 510(k) number is K981568.

When did MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 receive FDA 510(k) clearance?

MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 received FDA 510(k) clearance on 1998-08-21, under 510(k) number K981568.

Who is the listed applicant for MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800?

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

What is the FDA product code for MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800?

The FDA product code for MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 is GKZ.

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Other records listing Cdc Technologies, 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.

K983562MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700

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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