The following data is part of a premarket notification filed by Remel Co. with the FDA for Todd Hewitt W/cna (lim Broth).
| Device ID | K871447 |
| 510k Number | K871447 |
| Device Name: | TODD HEWITT W/CNA (LIM BROTH) |
| Classification | Culture Media, Selective Broth |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | James G Baxendale |
| Correspondent | James G Baxendale REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JSD |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-13 |
| Decision Date | 1987-05-13 |