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FDA 510(k)

HEK

K-Number: K842584 · 1984-07-27

ApplicantViromed Laboratories, Inc.
Decision Date1984-07-27
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEK is the device name listed in this FDA 510(k) record. The listed applicant is Viromed Laboratories, Inc.. It received FDA 510(k) clearance on 1984-07-27 under 510(k) number K842584. The device is classified under product code KIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEK?

HEK is a medical device that received FDA 510(k) clearance on 1984-07-27. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K842584.

When did HEK receive FDA 510(k) clearance?

HEK received FDA 510(k) clearance on 1984-07-27, under 510(k) number K842584.

Who is the listed applicant for HEK?

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

What is the FDA product code for HEK?

The FDA product code for HEK is KIR.

Other records listing Viromed Laboratories, Inc. as applicant

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Related Devices (Code: KIR)

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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