The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Mueller Hinton Ii Broth (cation-adjusted) With Lysed Horse Blood.
Device ID | K963036 |
510k Number | K963036 |
Device Name: | MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE 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 | Virginia C Weinknecht |
Correspondent | Virginia C Weinknecht 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 | 1996-08-05 |
Decision Date | 1996-10-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00382902979630 | K963036 | 000 |
30382902982686 | K963036 | 000 |