The following data is part of a premarket notification filed by Becton Dickinson Biosciences with the FDA for Bd Probetec Et Mycobacterium Tuberculosis Complex (ctb) Culture Identification Assay.
| Device ID | K000884 |
| 510k Number | K000884 |
| Device Name: | BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY |
| Classification | Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis |
| Applicant | BECTON DICKINSON BIOSCIENCES 7 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Colleen Rohrbeck |
| Correspondent | Colleen Rohrbeck BECTON DICKINSON BIOSCIENCES 7 LOVETON CIRCLE Sparks, MD 21152 |
| Product Code | NDZ |
| CFR Regulation Number | 866.3370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-20 |
| Decision Date | 2001-01-19 |