The following data is part of a premarket notification filed by Cnr Labs with the FDA for Microdilution Anaerobe Id. Panel.
Device ID | K781369 |
510k Number | K781369 |
Device Name: | MICRODILUTION ANAEROBE ID. PANEL |
Classification | Culture Media, Single Biochemical Test |
Applicant | CNR LABS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSF |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-08 |
Decision Date | 1978-10-03 |