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FDA 510(k)

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)

K-Number: K962353 · 1996-08-19

ApplicantPrinceton BioMeditech Corp.
Decision Date1996-08-19
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) 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 1996-08-19 under 510(k) number K962353. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)?

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) is a medical device that received FDA 510(k) clearance on 1996-08-19. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K962353.

When did ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) receive FDA 510(k) clearance?

ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) received FDA 510(k) clearance on 1996-08-19, under 510(k) number K962353.

Who is the listed applicant for ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)?

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 DOA 5 (THC/OPI/COC/MET OR AMP/PCP)?

The FDA product code for ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) is DIO.

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Related Devices (Code: DIO)

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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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