The following data is part of a premarket notification filed by Blue Ridge Media Co. with the FDA for Antimicrobial Suscep. Test, Mueller.
Device ID | K820846 |
510k Number | K820846 |
Device Name: | ANTIMICROBIAL SUSCEP. TEST, MUELLER |
Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
Applicant | BLUE RIDGE MEDIA CO. 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 | 1982-03-26 |
Decision Date | 1982-04-16 |