The following data is part of a premarket notification filed by Edge Biologicals, Inc. with the FDA for Mueller Hinton Agar.
| Device ID | K132491 |
| 510k Number | K132491 |
| Device Name: | MUELLER HINTON AGAR |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | EDGE BIOLOGICALS, INC. 598 NORTH SECOND ST. Memphis, TN 38105 |
| Contact | Ted A Pearson |
| Correspondent | Ted A Pearson EDGE BIOLOGICALS, INC. 598 NORTH SECOND ST. Memphis, TN 38105 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-08 |
| Decision Date | 2014-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B6453P240 | K132491 | 000 |