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FDA 510(k)

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500

K-Number: K981950 · 1998-11-03

ApplicantSysmex Corp.
Decision Date1998-11-03
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex Corp.. It received FDA 510(k) clearance on 1998-11-03 under 510(k) number K981950. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500?

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Sysmex Corp.. The 510(k) number is K981950.

When did SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 receive FDA 510(k) clearance?

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 received FDA 510(k) clearance on 1998-11-03, under 510(k) number K981950.

Who is the listed applicant for SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500?

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 R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500?

The FDA product code for SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 is GKL.

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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 ANALYZERK981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERK971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETERK964946SYSMEX CA-1000/SYSMEX CA-5000K964375SYSMEX SE/RAM-1

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Related Devices (Code: GKL)

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.

K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc.K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris DiagnosticsK071652HEMOCUE WBC SYSTEMHemocue ABK051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEMBayer Healthcare, LLCK050235IQ 200 URINE ANALYZER BODY FLUIDS MODULEIris International, Inc.K032677SYSMEX POCH-100ISysmex 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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