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FDA 510(k)

LIFESIGN DOA 4 (THC/OPI/COC/MET)

K-Number: K014193 · 2002-05-23

ApplicantPrinceton BioMeditech Corp.
Decision Date2002-05-23
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LIFESIGN DOA 4 (THC/OPI/COC/MET) 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 2002-05-23 under 510(k) number K014193. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESIGN DOA 4 (THC/OPI/COC/MET)?

LIFESIGN DOA 4 (THC/OPI/COC/MET) is a medical device that received FDA 510(k) clearance on 2002-05-23. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K014193.

When did LIFESIGN DOA 4 (THC/OPI/COC/MET) receive FDA 510(k) clearance?

LIFESIGN DOA 4 (THC/OPI/COC/MET) received FDA 510(k) clearance on 2002-05-23, under 510(k) number K014193.

Who is the listed applicant for LIFESIGN DOA 4 (THC/OPI/COC/MET)?

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 LIFESIGN DOA 4 (THC/OPI/COC/MET)?

The FDA product code for LIFESIGN DOA 4 (THC/OPI/COC/MET) is LDJ.

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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.

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