The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bactec 9240 System.
| Device ID | K915796 |
| 510k Number | K915796 |
| Device Name: | BACTEC 9240 SYSTEM |
| Classification | System, Blood Culturing |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 33 MANSELL COURT P.O. BOX 337 Roswell, GA 30077 |
| Contact | Frank J Swenson |
| Correspondent | Frank J Swenson BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 33 MANSELL COURT P.O. BOX 337 Roswell, GA 30077 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904455699 | K915796 | 000 |
| 00382904422967 | K915796 | 000 |
| 30382904421916 | K915796 | 000 |
| 00382904413866 | K915796 | 000 |
| 00382904413859 | K915796 | 000 |