The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agars.
| Device ID | K945911 |
| 510k Number | K945911 |
| Device Name: | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | BIOCLINICAL SYSTEMS, INC. 9040 JUNCTION DR. Annapolis Junction, MD 20701 |
| Contact | Kathryn B Powers |
| Correspondent | Kathryn B Powers BIOCLINICAL SYSTEMS, INC. 9040 JUNCTION DR. Annapolis Junction, MD 20701 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-02 |
| Decision Date | 1995-04-04 |