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 |