The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Differentiation Disks Sps.
| Device ID | K840804 | 
| 510k Number | K840804 | 
| Device Name: | DIFFERENTIATION DISKS SPS | 
| Classification | Discs, Strips And Reagents, Microorganism Differentiation | 
| Applicant | DIFCO LABORATORIES, INC. 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 |