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FDA 510(k)

SYSMEX UF-100

K-Number: K961054 · 1996-10-28

ApplicantSysmex Corp.
Decision Date1996-10-28
Product CodeLKM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX UF-100 is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex Corp.. It received FDA 510(k) clearance on 1996-10-28 under 510(k) number K961054. 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 SYSMEX UF-100?

SYSMEX UF-100 is a medical device that received FDA 510(k) clearance on 1996-10-28. The listed applicant is Sysmex Corp.. The 510(k) number is K961054.

When did SYSMEX UF-100 receive FDA 510(k) clearance?

SYSMEX UF-100 received FDA 510(k) clearance on 1996-10-28, under 510(k) number K961054.

Who is the listed applicant for SYSMEX UF-100?

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

What is the FDA product code for SYSMEX UF-100?

The FDA product code for SYSMEX UF-100 is LKM.

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Other records listing Sysmex 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.

K012372SYSMEX UF-50K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZERK981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERK971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERK964946SYSMEX CA-1000/SYSMEX CA-5000

View all 18 devices →

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

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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