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FDA 510(k)

TECHNICON H6000 HEMATOLOGY SYSTEM

K-Number: K801155 · 1980-06-09

ApplicantTechnicon Instruments Corp.
Decision Date1980-06-09
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TECHNICON H6000 HEMATOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1980-06-09 under 510(k) number K801155. 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 TECHNICON H6000 HEMATOLOGY SYSTEM?

TECHNICON H6000 HEMATOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1980-06-09. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K801155.

When did TECHNICON H6000 HEMATOLOGY SYSTEM receive FDA 510(k) clearance?

TECHNICON H6000 HEMATOLOGY SYSTEM received FDA 510(k) clearance on 1980-06-09, under 510(k) number K801155.

Who is the listed applicant for TECHNICON H6000 HEMATOLOGY SYSTEM?

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

What is the FDA product code for TECHNICON H6000 HEMATOLOGY SYSTEM?

The FDA product code for TECHNICON H6000 HEMATOLOGY SYSTEM 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.

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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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