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FDA 510(k)

STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE

K-Number: K062565 · 2007-02-20

ApplicantPrinceton BioMeditech Corp.
Decision Date2007-02-20
Product CodeMKU
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2007-02-20 under 510(k) number K062565. The device is classified under product code MKU. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE?

STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE is a medical device that received FDA 510(k) clearance on 2007-02-20. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K062565.

When did STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE receive FDA 510(k) clearance?

STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE received FDA 510(k) clearance on 2007-02-20, under 510(k) number K062565.

Who is the listed applicant for STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE?

The FDA product code for STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE is MKU.

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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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