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FDA 510(k)

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT

K-Number: K822823 · 1982-10-18

ApplicantEko Scann AB
Decision Date1982-10-18
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT is the device name listed in this FDA 510(k) record. The listed applicant is Eko Scann AB. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822823. The device is classified under product code LKM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT?

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Eko Scann AB. The 510(k) number is K822823.

When did HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT receive FDA 510(k) clearance?

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822823.

Who is the listed applicant for HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT?

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

What is the FDA product code for HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT?

The FDA product code for HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT is LKM.

Related Clinical Trials

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.

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Other records listing Eko Scann AB 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.

K822873DEVETHERM

Related Devices (Code: LKM)

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.

K252580iQ200 SeriesBeckman Coulter, Inc.K232416AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc.K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.K200811cobas u 701 microscopy analyzerRoche DiagnosticsK171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.K093861IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLEIris International, 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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