The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Reagents.
Device ID | K840030 |
510k Number | K840030 |
Device Name: | REAGENTS |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | ANAEROBE SYSTEMS 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 | 1984-01-05 |
Decision Date | 1984-03-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REAGENTS 75221406 not registered Dead/Abandoned |
Harmony Laboratories, Inc. 1997-01-06 |