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FDA 510(k)

FLUID, RHEMOX W LYSING

K-Number: K790029 · 1979-02-26

ApplicantSysmex Corp.
Decision Date1979-02-26
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLUID, RHEMOX W 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 1979-02-26 under 510(k) number K790029. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID, RHEMOX W LYSING?

FLUID, RHEMOX W LYSING is a medical device that received FDA 510(k) clearance on 1979-02-26. The listed applicant is Sysmex Corp.. The 510(k) number is K790029.

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

FLUID, RHEMOX W LYSING received FDA 510(k) clearance on 1979-02-26, under 510(k) number K790029.

Who is the listed applicant for FLUID, RHEMOX W 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 W LYSING?

The FDA product code for FLUID, RHEMOX W LYSING is GGK.

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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: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, 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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