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FDA 510(k)

HEMOSAFE

K-Number: K800346 · 1980-04-16

ApplicantMed Lab Systems, Inc.
Decision Date1980-04-16
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOSAFE is the device name listed in this FDA 510(k) record. The listed applicant is Med Lab Systems, Inc.. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800346. 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 HEMOSAFE?

HEMOSAFE is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Med Lab Systems, Inc.. The 510(k) number is K800346.

When did HEMOSAFE receive FDA 510(k) clearance?

HEMOSAFE received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800346.

Who is the listed applicant for HEMOSAFE?

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

What is the FDA product code for HEMOSAFE?

The FDA product code for HEMOSAFE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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