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FDA 510(k)

ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY

K-Number: K962669 · 1996-08-15

ApplicantPrinceton BioMeditech Corp.
Decision Date1996-08-15
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE 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 1996-08-15 under 510(k) number K962669. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY?

ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K962669.

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

ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962669.

Who is the listed applicant for ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE 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 BAR-RAPID ONE-STEP BARBITURATE ASSAY?

The FDA product code for ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY is DIS.

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Related Devices (Code: DIS)

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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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