The following data is part of a premarket notification filed by Preferred Micro-media with the FDA for Macconkey Agar.
Device ID | K851586 |
510k Number | K851586 |
Device Name: | MACCONKEY AGAR |
Classification | Culture Media, Selective And Differential |
Applicant | PREFERRED MICRO-MEDIA 5223 TELEGRAPH RD. Toledo, OH 43612 |
Contact | Robert Scott |
Correspondent | Robert Scott PREFERRED MICRO-MEDIA 5223 TELEGRAPH RD. Toledo, OH 43612 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-16 |
Decision Date | 1985-04-30 |