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FDA 510(k)

DATACELL 18MS

K-Number: K945678 · 1995-09-12

ApplicantDanam Electronics
Decision Date1995-09-12
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DATACELL 18MS is the device name listed in this FDA 510(k) record. The listed applicant is Danam Electronics. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K945678. 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 DATACELL 18MS?

DATACELL 18MS is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Danam Electronics. The 510(k) number is K945678.

When did DATACELL 18MS receive FDA 510(k) clearance?

DATACELL 18MS received FDA 510(k) clearance on 1995-09-12, under 510(k) number K945678.

Who is the listed applicant for DATACELL 18MS?

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

What is the FDA product code for DATACELL 18MS?

The FDA product code for DATACELL 18MS is GKZ.

Related Clinical Trials

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Other records listing Danam Electronics 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.

K910283DANAM DATACELL-18K892205DANAM VECTOR-8+K840649DANAM ELEC. SA-1000

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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