The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Mueller Hinton Agar With 5% Sheep Blood.
Device ID | K960420 |
510k Number | K960420 |
Device Name: | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD |
Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
Contact | Judith J Smith |
Correspondent | Judith J Smith BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
Product Code | JTZ |
CFR Regulation Number | 866.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-29 |
Decision Date | 1996-04-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30382902218013 | K960420 | 000 |