The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Crystal Enteric/nonfermenter Id System.
Device ID | K926018 |
510k Number | K926018 |
Device Name: | CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM |
Classification | Kit, Identification, Enterobacteriaceae |
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 | JSS |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-30 |
Decision Date | 1993-03-11 |