The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Bactec Myco/f Lytic Culture Vials.
| Device ID | K970512 |
| 510k Number | K970512 |
| Device Name: | BACTEC MYCO/F LYTIC CULTURE VIALS |
| Classification | System, Blood Culturing |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Dennis R Mertz |
| Correspondent | Dennis R Mertz BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-11 |
| Decision Date | 1998-01-08 |
| Summary: | summary |