BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
FDA 510(k) clearance K000884 · decided 2001-01-19
Clearance details
- K-number
- K000884
- Device name
- BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
- Applicant
- Becton Dickinson Biosciences
- Decision
- Substantially Equivalent
- Date received
- 2000-03-20
- Decision date
- 2001-01-19
- Days to decision
- 305 days
- Clearance type
- Traditional
- Product code
- NDZ
- Device class
- 1
- Regulation number
- 866.3370
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.