The following data is part of a premarket notification filed by Becton Dickinson Diagnostic Instrument Systems with the FDA for Bactec(r) 9000tb System.
| Device ID | K946268 |
| 510k Number | K946268 |
| Device Name: | BACTEC(R) 9000TB SYSTEM |
| Classification | System, Blood Culturing |
| Applicant | BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Dennis R Mertz |
| Correspondent | Dennis R Mertz BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS 7 LOVETON CIRCLE 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 | 1994-12-23 |
| Decision Date | 1996-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904421893 | K946268 | 000 |
| 30382904421886 | K946268 | 000 |