The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Tigecycline 15ug Bbl Sensi-disc.
| Device ID | K052853 |
| 510k Number | K052853 |
| Device Name: | TIGECYCLINE 15UG BBL SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 |
| Contact | Dainelle Clark |
| Correspondent | Dainelle Clark BECTON DICKINSON & CO. 7 LOVETON CIR. 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 | 2005-10-11 |
| Decision Date | 2005-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902320876 | K052853 | 000 |
| 30382902322086 | K052853 | 000 |