The following data is part of a premarket notification filed by Microline Scientific with the FDA for Culture Medium For Antimicrobial Suscep.
Device ID | K841834 |
510k Number | K841834 |
Device Name: | CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP |
Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
Applicant | MICROLINE SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTZ |
CFR Regulation Number | 866.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-17 |
Decision Date | 1984-05-14 |