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FDA 510(k)

ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY

K-Number: K962672 · 1996-08-30

ApplicantPrinceton BioMeditech Corp.
Decision Date1996-08-30
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY 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 1996-08-30 under 510(k) number K962672. 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-RAPID ONE-STEP BENZODIAZEPINE ASSAY?

ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY is a medical device that received FDA 510(k) clearance on 1996-08-30. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K962672.

When did ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY receive FDA 510(k) clearance?

ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY received FDA 510(k) clearance on 1996-08-30, under 510(k) number K962672.

Who is the listed applicant for ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY?

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-RAPID ONE-STEP BENZODIAZEPINE ASSAY?

The FDA product code for ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY 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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