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 |