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FDA 510(k)

FLUID, RHEMOX-HB LYSING

K-Number: K790030 · 1979-02-08

ApplicantSysmex Corp.
Decision Date1979-02-08
Product CodeGKR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLUID, RHEMOX-HB LYSING is the device name listed in this FDA 510(k) record. The listed applicant is Sysmex Corp.. It received FDA 510(k) clearance on 1979-02-08 under 510(k) number K790030. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID, RHEMOX-HB LYSING?

FLUID, RHEMOX-HB LYSING is a medical device that received FDA 510(k) clearance on 1979-02-08. The listed applicant is Sysmex Corp.. The 510(k) number is K790030.

When did FLUID, RHEMOX-HB LYSING receive FDA 510(k) clearance?

FLUID, RHEMOX-HB LYSING received FDA 510(k) clearance on 1979-02-08, under 510(k) number K790030.

Who is the listed applicant for FLUID, RHEMOX-HB LYSING?

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 FLUID, RHEMOX-HB LYSING?

The FDA product code for FLUID, RHEMOX-HB LYSING is GKR.

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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

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Related Devices (Code: GKR)

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K201217HemoCue Hb 301 SystemHemocue ABK200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbHK181751HemoCue Hb 801 SystemHemocue ABK182298hemochroma PLUS SystemImmunostics Inc.,K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbHK163465hemochroma PLUS SystemImmunostics 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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