The following data is part of a premarket notification filed by Preferred Micro-media with the FDA for Mueller Hinton Agar & Mueller Hinton Agar W/5% She.
| Device ID | K851589 |
| 510k Number | K851589 |
| Device Name: | MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | PREFERRED MICRO-MEDIA 5223 TELEGRAPH RD. TOLEDO, OH 43612 |
| Contact | ROBERT SCOTT |
| Correspondent | ROBERT SCOTT PREFERRED MICRO-MEDIA 5223 TELEGRAPH RD. TOLEDO, OH 43612 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-04-30 |