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 |