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FDA 510(k)

ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO

K-Number: K991079 · 1999-04-15

ApplicantPrinceton BioMeditech Corp.
Decision Date1999-04-15
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO 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 1999-04-15 under 510(k) number K991079. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO?

ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO is a medical device that received FDA 510(k) clearance on 1999-04-15. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K991079.

When did ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO receive FDA 510(k) clearance?

ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO received FDA 510(k) clearance on 1999-04-15, under 510(k) number K991079.

Who is the listed applicant for ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO?

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 BZO, BIOSIGN BZO, STATUS BZO?

The FDA product code for ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO is JXM.

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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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