510(k) K000884
- Device
- BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
- Applicant
- BECTON DICKINSON BIOSCIENCES
- 510(k) number
- K000884
- Product code
- NDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-01-19
- Date received
- 2000-03-20
- Regulation
- 866.3370
- Classification name
- Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLLEEN ROHRBECK
- Address
- 7loveton Cir. Sparks MD US 21152 21152
FDA Registration Numbers#
- 2243471
Source Documents#
Legacy Summary#
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FDA Review#
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