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FDA 510(k)

DANAM DATACELL-18

K-Number: K910283 · 1991-04-12

ApplicantDanam Electronics
Decision Date1991-04-12
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DANAM DATACELL-18 is the device name listed in this FDA 510(k) record. The listed applicant is Danam Electronics. It received FDA 510(k) clearance on 1991-04-12 under 510(k) number K910283. 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 DANAM DATACELL-18?

DANAM DATACELL-18 is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Danam Electronics. The 510(k) number is K910283.

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

DANAM DATACELL-18 received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910283.

Who is the listed applicant for DANAM DATACELL-18?

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 DANAM DATACELL-18?

The FDA product code for DANAM DATACELL-18 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.

K945678DATACELL 18MSK892205DANAM 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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