The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Cefepime, 30 Mcg, Sensi-disc.
| Device ID | K961188 |
| 510k Number | K961188 |
| Device Name: | CEFEPIME, 30 MCG, SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Virginia C Weinknecht |
| Correspondent | Virginia C Weinknecht 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 | 1996-03-26 |
| Decision Date | 1996-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382902316962 | K961188 | 000 |