The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Cefotaxime/clavulanic, 30/10ug, Bbl Sensi-disc And Ceftazidime/clavulanic Acid, 30/10ug, Bbl Sensi-disc.
| Device ID | K993577 |
| 510k Number | K993577 |
| Device Name: | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Monica E Giguere |
| Correspondent | Monica E Giguere 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 | 1999-10-21 |
| Decision Date | 1999-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902317531 | K993577 | 000 |
| 00382902317517 | K993577 | 000 |
| 30382902317549 | K993577 | 000 |
| 30382902317525 | K993577 | 000 |