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FDA 510(k)

HEMO-W SYSTEM

K-Number: K781628 · 1978-10-27

ApplicantCoulter Electronics, Inc.
Decision Date1978-10-27
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMO-W SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1978-10-27 under 510(k) number K781628. 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 HEMO-W SYSTEM?

HEMO-W SYSTEM is a medical device that received FDA 510(k) clearance on 1978-10-27. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K781628.

When did HEMO-W SYSTEM receive FDA 510(k) clearance?

HEMO-W SYSTEM received FDA 510(k) clearance on 1978-10-27, under 510(k) number K781628.

Who is the listed applicant for HEMO-W SYSTEM?

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

What is the FDA product code for HEMO-W SYSTEM?

The FDA product code for HEMO-W SYSTEM is GKL.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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