510(k) K000884
K000884 is an FDA 510(k) premarket notification submitted by Becton Dickinson Biosciences for the device "BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY". The FDA issued a decision of Substantially Equivalent on January 19, 2001. The device falls under product code NDZ (Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis), a Class I device regulated under 21 CFR 866.3370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2001
- Date Received
- March 20, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
- Device Class
- Class I
- Regulation Number
- 866.3370
- Review Panel
- MI
- Submission Type