The following data is part of a premarket notification filed by Remel Co. with the FDA for Macconkey W/sorbitol.
Device ID | K872188 |
510k Number | K872188 |
Device Name: | MACCONKEY W/SORBITOL |
Classification | Culture Media, 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 | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-08 |
Decision Date | 1987-06-24 |