The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Remel Spectra Esbl.
| Device ID | K162620 |
| 510k Number | K162620 |
| Device Name: | Remel Spectra ESBL |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | REMEL, INC. 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Contact | Cynthia Knapp |
| Correspondent | Cynthia Knapp REMEL, INC. 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2017-05-01 |
| Summary: | summary |