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FDA 510(k)

ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP

K-Number: K981771 · 1998-06-12

ApplicantPrinceton BioMeditech Corp.
Decision Date1998-06-12
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP 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 1998-06-12 under 510(k) number K981771. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP?

ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP is a medical device that received FDA 510(k) clearance on 1998-06-12. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K981771.

When did ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP receive FDA 510(k) clearance?

ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP received FDA 510(k) clearance on 1998-06-12, under 510(k) number K981771.

Who is the listed applicant for ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP?

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 MOP, BIOSIGN MOP, STAUS DS MOP?

The FDA product code for ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP is DJG.

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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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