FDA 510(k)

ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.

K-Number: K001225 · 2000-05-17

Decision Date2000-05-17

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. 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 2000-05-17 under 510(k) number K001225. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.?

ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K001225.

When did ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. receive FDA 510(k) clearance?

ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. received FDA 510(k) clearance on 2000-05-17, under 510(k) number K001225.

Who is the listed applicant for ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.?

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 ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.?

The FDA product code for ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. is DKZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.