The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Strips.
Device ID | K840029 |
510k Number | K840029 |
Device Name: | STRIPS |
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 |
---|---|
STRIPS 78207174 not registered Dead/Abandoned |
International Provisions, Inc. 2003-01-26 |
STRIPS 77706456 not registered Dead/Abandoned |
NACIONAL DE ALIMENTOS Y HELADOS, S.A. DE C.V. 2009-04-03 |