The following data is part of a premarket notification filed by Remel Co. with the FDA for Thermonuclease Agar W/toluidine Blue.
| Device ID | K864205 |
| 510k Number | K864205 |
| Device Name: | THERMONUCLEASE AGAR W/TOLUIDINE BLUE |
| Classification | Culture Media, Non-selective And Differential |
| 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 | JSH |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-27 |
| Decision Date | 1986-11-24 |