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FDA 510(k)

MDCK

K-Number: K852394 · 1985-07-12

ApplicantViromed Laboratories, Inc.
Decision Date1985-07-12
Product CodeKIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MDCK 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 1985-07-12 under 510(k) number K852394. 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 MDCK?

MDCK is a medical device that received FDA 510(k) clearance on 1985-07-12. The listed applicant is Viromed Laboratories, Inc.. The 510(k) number is K852394.

When did MDCK receive FDA 510(k) clearance?

MDCK received FDA 510(k) clearance on 1985-07-12, under 510(k) number K852394.

Who is the listed applicant for MDCK?

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 MDCK?

The FDA product code for MDCK 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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