The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Ofloxacin, 5 Mcg Sensi-disc.
| Device ID | K910506 |
| 510k Number | K910506 |
| Device Name: | OFLOXACIN, 5 MCG SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Russell Arnsberger |
| Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-05 |
| Decision Date | 1991-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902316726 | K910506 | 000 |