The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Bactec Lytic/10 Anaerobic/f (plastic).
| Device ID | K123903 |
| 510k Number | K123903 |
| Device Name: | BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC) |
| Classification | System, Blood Culturing |
| Applicant | BECTON DICKINSON & CO. 7 LOVETON CIR., MC 614 Sparks, MD 21152 |
| Contact | Paul Swift |
| Correspondent | Paul Swift BECTON DICKINSON & CO. 7 LOVETON CIR., MC 614 Sparks, MD 21152 |
| Product Code | MDB |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-19 |
| Decision Date | 2013-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904420216 | K123903 | 000 |