The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Cefaclor Sensi-disc.
Device ID | K855135 |
510k Number | K855135 |
Device Name: | CEFACLOR SENSI-DISC |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus, NJ 07652 |
Contact | Russell Arnsberger |
Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACK CENTRE DR. P.O.BOX 2224 Paramus, NJ 07652 |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-23 |
Decision Date | 1986-01-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382902316535 | K855135 | 000 |