The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Gatifloxacin, 5 Ug, Bbl Sensi-disc.
| Device ID | K000829 |
| 510k Number | K000829 |
| Device Name: | GATIFLOXACIN, 5 UG, BBL SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Bradford Spring |
| Correspondent | Bradford Spring BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 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 | 2000-03-14 |
| Decision Date | 2000-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902317600 | K000829 | 000 |