The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for G C Ii Agar With Sensivitalex.
Device ID | K932879 |
510k Number | K932879 |
Device Name: | G C II AGAR WITH SENSIVITALEX |
Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
Contact | Robert E James |
Correspondent | Robert E James BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
Product Code | JSO |
CFR Regulation Number | 866.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-14 |
Decision Date | 1993-09-21 |