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FDA 510(k)

BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY

K-Number: K000884 · 2001-01-19

ApplicantBecton Dickinson Biosciences
Decision Date2001-01-19
Product CodeNDZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Biosciences. It received FDA 510(k) clearance on 2001-01-19 under 510(k) number K000884. The device is classified under product code NDZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY?

BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY is a medical device that received FDA 510(k) clearance on 2001-01-19. The listed applicant is Becton Dickinson Biosciences. The 510(k) number is K000884.

When did BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY receive FDA 510(k) clearance?

BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY received FDA 510(k) clearance on 2001-01-19, under 510(k) number K000884.

Who is the listed applicant for BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY?

The FDA 510(k) record lists Becton Dickinson Biosciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY?

The FDA product code for BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY is NDZ.

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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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