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FDA 510(k)

WHOLE BLOOD PLATELET COUNTER -2510

K-Number: K760765 · 1976-12-30

ApplicantClay Adams, Div. Becton Dickinson & Co.
Decision Date1976-12-30
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WHOLE BLOOD PLATELET COUNTER -2510 is the device name listed in this FDA 510(k) record. The listed applicant is Clay Adams, Div. Becton Dickinson & Co.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K760765. 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 WHOLE BLOOD PLATELET COUNTER -2510?

WHOLE BLOOD PLATELET COUNTER -2510 is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is Clay Adams, Div. Becton Dickinson & Co.. The 510(k) number is K760765.

When did WHOLE BLOOD PLATELET COUNTER -2510 receive FDA 510(k) clearance?

WHOLE BLOOD PLATELET COUNTER -2510 received FDA 510(k) clearance on 1976-12-30, under 510(k) number K760765.

Who is the listed applicant for WHOLE BLOOD PLATELET COUNTER -2510?

The FDA 510(k) record lists Clay Adams, Div. Becton Dickinson & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WHOLE BLOOD PLATELET COUNTER -2510?

The FDA product code for WHOLE BLOOD PLATELET COUNTER -2510 is GKL.

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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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