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FDA 510(k)

HEMACHECK

K-Number: K781562 · 1978-11-15

ApplicantVickers America Medical Corp.
Decision Date1978-11-15
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMACHECK is the device name listed in this FDA 510(k) record. The listed applicant is Vickers America Medical Corp.. It received FDA 510(k) clearance on 1978-11-15 under 510(k) number K781562. 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 HEMACHECK?

HEMACHECK is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Vickers America Medical Corp.. The 510(k) number is K781562.

When did HEMACHECK receive FDA 510(k) clearance?

HEMACHECK received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781562.

Who is the listed applicant for HEMACHECK?

The FDA 510(k) record lists Vickers America Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMACHECK?

The FDA product code for HEMACHECK is GKL.

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Other records listing Vickers America Medical 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.

K840823TREONIC C30K831838LABORATORY DATA MGMT SYSTEM SDMSK830748RESUSCITAIREK830936TREONIC IP5K813239OXYGENAIRE NURING INCUBATORK813238NEOCARE BABY-CONTROLLED INCUBATOR

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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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