The following data is part of a premarket notification filed by Becton Dickinson And Company (bd) with the FDA for Ceftaroline 30 Micrograms, Bbl(tm) Sensi-disc(tm).
| Device ID | K112586 |
| 510k Number | K112586 |
| Device Name: | CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON AND COMPANY (BD) 7 LOVETON CIRCLE MC 614 Sparks, MD 21152 |
| Contact | Katie Coyle |
| Correspondent | Katie Coyle BECTON DICKINSON AND COMPANY (BD) 7 LOVETON CIRCLE MC 614 Sparks, MD 21152 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-06 |
| Decision Date | 2011-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902322314 | K112586 | 000 |