The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Cefprozil 30mcg, Sensi Disc.
| Device ID | K920473 |
| 510k Number | K920473 |
| Device Name: | CEFPROZIL 30MCG, SENSI DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Robert E James |
| Correspondent | Robert E James BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-28 |
| Decision Date | 1992-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902316849 | K920473 | 000 |