The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bbl Chromagar 0157.
Device ID | K070691 |
510k Number | K070691 |
Device Name: | BBL CHROMAGAR 0157 |
Classification | Culture Media, Selective And Differential |
Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
Contact | Dennis R Mertz |
Correspondent | Dennis R Mertz BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-13 |
Decision Date | 2007-11-20 |
Summary: | summary |