The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Bbl Sensi-disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks.
| Device ID | K152516 |
| 510k Number | K152516 |
| Device Name: | BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Laura Stewart |
| Correspondent | Laura Stewart BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2015-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902322184 | K152516 | 000 |