The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bactec Mgit 960 Sire Kits.
| Device ID | K014123 |
| 510k Number | K014123 |
| Device Name: | BACTEC MGIT 960 SIRE KITS |
| Classification | Susceptibility Test Powders, Antimycobacterial |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Jody J Hoffmann |
| Correspondent | Jody J Hoffmann BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | MJA |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-17 |
| Decision Date | 2002-04-19 |
| Summary: | summary |