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FDA 510(k)

TECHNICON H*1 SYSTEM (MPXI)

K-Number: K853027 · 1986-02-05

ApplicantTechnicon Instruments Corp.
Decision Date1986-02-05
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TECHNICON H*1 SYSTEM (MPXI) 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 1986-02-05 under 510(k) number K853027. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON H*1 SYSTEM (MPXI)?

TECHNICON H*1 SYSTEM (MPXI) is a medical device that received FDA 510(k) clearance on 1986-02-05. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K853027.

When did TECHNICON H*1 SYSTEM (MPXI) receive FDA 510(k) clearance?

TECHNICON H*1 SYSTEM (MPXI) received FDA 510(k) clearance on 1986-02-05, under 510(k) number K853027.

Who is the listed applicant for TECHNICON H*1 SYSTEM (MPXI)?

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 H*1 SYSTEM (MPXI)?

The FDA product code for TECHNICON H*1 SYSTEM (MPXI) is GKZ.

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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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