NDZ — Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis Class I
FDA product code NDZ covers "Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis", a Class I medical device regulated under 21 CFR 866.3370. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NDZ
- Device Class
- Class I
- Regulation Number
- 866.3370
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K000884 | becton dickinson biosciences | BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION A | January 19, 2001 |