The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Cefdinir, 5 Ug, Sensi-disc.
| Device ID | K981517 |
| 510k Number | K981517 |
| Device Name: | CEFDINIR, 5 UG, SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Virginia C Weinknecht |
| Correspondent | Virginia C Weinknecht BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. 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 | 1998-04-28 |
| Decision Date | 1998-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902317135 | K981517 | 000 |