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FDA 510(k)

EXACT ONE(TM) HEMATOLOGY ANALYZER

K-Number: K900276 · 1990-04-16

ApplicantExact Science, Inc.
Decision Date1990-04-16
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EXACT ONE(TM) HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Exact Science, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K900276. 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 EXACT ONE(TM) HEMATOLOGY ANALYZER?

EXACT ONE(TM) HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Exact Science, Inc.. The 510(k) number is K900276.

When did EXACT ONE(TM) HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

EXACT ONE(TM) HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1990-04-16, under 510(k) number K900276.

Who is the listed applicant for EXACT ONE(TM) HEMATOLOGY ANALYZER?

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

What is the FDA product code for EXACT ONE(TM) HEMATOLOGY ANALYZER?

The FDA product code for EXACT ONE(TM) HEMATOLOGY ANALYZER is GKZ.

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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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