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FDA 510(k)

MEDICOUNT DEKA HEMATOLOGY ANALYZER

K-Number: K942525 · 1996-06-05

ApplicantCea America Corp.
Decision Date1996-06-05
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MEDICOUNT DEKA HEMATOLOGY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cea America Corp.. It received FDA 510(k) clearance on 1996-06-05 under 510(k) number K942525. 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 MEDICOUNT DEKA HEMATOLOGY ANALYZER?

MEDICOUNT DEKA HEMATOLOGY ANALYZER is a medical device that received FDA 510(k) clearance on 1996-06-05. The listed applicant is Cea America Corp.. The 510(k) number is K942525.

When did MEDICOUNT DEKA HEMATOLOGY ANALYZER receive FDA 510(k) clearance?

MEDICOUNT DEKA HEMATOLOGY ANALYZER received FDA 510(k) clearance on 1996-06-05, under 510(k) number K942525.

Who is the listed applicant for MEDICOUNT DEKA HEMATOLOGY ANALYZER?

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

What is the FDA product code for MEDICOUNT DEKA HEMATOLOGY ANALYZER?

The FDA product code for MEDICOUNT DEKA HEMATOLOGY ANALYZER is GKZ.

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Other records listing Cea America 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.

K834614WILCOR-XR RP-L MEDICAL FILMK834613WILCOR-XR RP MEDICAL FILMK834612WILCOR-XR RP-OG MEDICAL FILMK834611SINGUL-XR RP NON SCREEN MED. FILM

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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