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FDA 510(k)

STATUS CUP ACCUSIGN CUP

K-Number: K991751 · 1999-06-18

ApplicantPrinceton BioMeditech Corp.
Decision Date1999-06-18
Product CodeDKE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STATUS CUP ACCUSIGN CUP 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 1999-06-18 under 510(k) number K991751. The device is classified under product code DKE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATUS CUP ACCUSIGN CUP?

STATUS CUP ACCUSIGN CUP is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K991751.

When did STATUS CUP ACCUSIGN CUP receive FDA 510(k) clearance?

STATUS CUP ACCUSIGN CUP received FDA 510(k) clearance on 1999-06-18, under 510(k) number K991751.

Who is the listed applicant for STATUS CUP ACCUSIGN CUP?

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 CUP ACCUSIGN CUP?

The FDA product code for STATUS CUP ACCUSIGN CUP is DKE.

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Other records listing Princeton BioMeditech Corp. as applicant

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Related Devices (Code: DKE)

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.

K003687VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COCMedtox Diagnostics, Inc.K994405INSTANT-VIEW MARIJUANA URINE CASSETTE TESTAlfa Scientific Designs, Inc.K992068STATUS STIK, ACCUSIGN STIKPrinceton BioMeditech Corp.K991078ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8Princeton BioMeditech Corp.K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PPrinceton BioMeditech Corp.K982211PROFILE-II MODEL 600582Medtox Diagnostics, Inc.

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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