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 |