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FDA 510(k)

COUNTER, BLOOD CELL & HEMATOCRIT

K-Number: K770034 · 1977-02-16

ApplicantMallinckrodt Critical Care
Decision Date1977-02-16
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COUNTER, BLOOD CELL & HEMATOCRIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1977-02-16 under 510(k) number K770034. 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 COUNTER, BLOOD CELL & HEMATOCRIT?

COUNTER, BLOOD CELL & HEMATOCRIT is a medical device that received FDA 510(k) clearance on 1977-02-16. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K770034.

When did COUNTER, BLOOD CELL & HEMATOCRIT receive FDA 510(k) clearance?

COUNTER, BLOOD CELL & HEMATOCRIT received FDA 510(k) clearance on 1977-02-16, under 510(k) number K770034.

Who is the listed applicant for COUNTER, BLOOD CELL & HEMATOCRIT?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COUNTER, BLOOD CELL & HEMATOCRIT?

The FDA product code for COUNTER, BLOOD CELL & HEMATOCRIT is GKL.

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Other records listing Mallinckrodt Critical Care as applicant

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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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