The following data is part of a premarket notification filed by Remel Co. with the FDA for Microdase.
Device ID | K840819 |
510k Number | K840819 |
Device Name: | MICRODASE |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | REMEL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-24 |
Decision Date | 1984-03-23 |