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FDA 510(k)

NICALERT

K-Number: K021688 · 2002-10-18

ApplicantNymox Pharmaceutical Corporation
Decision Date2002-10-18
Product CodeMRS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

NICALERT is the device name listed in this FDA 510(k) record. The listed applicant is Nymox Pharmaceutical Corporation. It received FDA 510(k) clearance on 2002-10-18 under 510(k) number K021688. The device is classified under product code MRS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICALERT?

NICALERT is a medical device that received FDA 510(k) clearance on 2002-10-18. The listed applicant is Nymox Pharmaceutical Corporation. The 510(k) number is K021688.

When did NICALERT receive FDA 510(k) clearance?

NICALERT received FDA 510(k) clearance on 2002-10-18, under 510(k) number K021688.

Who is the listed applicant for NICALERT?

The FDA 510(k) record lists Nymox Pharmaceutical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICALERT?

The FDA product code for NICALERT is MRS.

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Related Devices (Code: MRS)

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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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