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FDA 510(k)

TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.

K-Number: K852988 · 1986-01-21

ApplicantTechnicon Instruments Corp.
Decision Date1986-01-21
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. 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 1986-01-21 under 510(k) number K852988. 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 SUB-CLASSIFICATION LUC CAT.?

TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K852988.

When did TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. receive FDA 510(k) clearance?

TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. received FDA 510(k) clearance on 1986-01-21, under 510(k) number K852988.

Who is the listed applicant for TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.?

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 SUB-CLASSIFICATION LUC CAT.?

The FDA product code for TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. is GKZ.

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Other records listing Technicon Instruments Corp. as applicant

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Related Devices (Code: 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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