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FDA 510(k)

SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM

K-Number: K882767 · 1988-07-18

ApplicantToa Medical Electronics USA, Inc.
Decision Date1988-07-18
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1988-07-18 under 510(k) number K882767. The device is classified under product code GKH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM?

SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM is a medical device that received FDA 510(k) clearance on 1988-07-18. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K882767.

When did SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM receive FDA 510(k) clearance?

SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM received FDA 510(k) clearance on 1988-07-18, under 510(k) number K882767.

Who is the listed applicant for SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM?

The FDA 510(k) record lists Toa Medical Electronics USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM?

The FDA product code for SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM is GKH.

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Other records listing Toa Medical Electronics USA, Inc. 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.

K936023SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZERK933886TOA MEDICAL ELECTRONICS CA-5000K931149CA-1000 AUTOMATED COAGULATION ANALYZERK920544SYSMEX HEMATOLOGY SYSTEM ACCESSORIESK914744SYSMEX NE-1500, MODIFICATIONK912494SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER

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Related Devices (Code: GKH)

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.

K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLCK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon Corp.K021150COULTER CELLPREPBeckman Coulter, Inc.K935953COULTER MULTI Q PREPCoulter Corp.K923530COULTER MULTI-Q-PREPCoulter Electronics, 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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