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FDA 510(k)

BHK-21

K-Number: K843250 · 1984-09-06

ApplicantViromed Laboratories, Inc.
Decision Date1984-09-06
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BHK-21 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 1984-09-06 under 510(k) number K843250. 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 BHK-21?

BHK-21 is a medical device that received FDA 510(k) clearance on 1984-09-06. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K843250.

When did BHK-21 receive FDA 510(k) clearance?

BHK-21 received FDA 510(k) clearance on 1984-09-06, under 510(k) number K843250.

Who is the listed applicant for BHK-21?

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 BHK-21?

The FDA product code for BHK-21 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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