The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Ana-check.
| Device ID | K831463 | 
| 510k Number | K831463 | 
| Device Name: | ANA-CHECK | 
| Classification | Antinuclear Antibody, Antigen, Control | 
| Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | LKJ | 
| CFR Regulation Number | 866.5100 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1983-05-06 | 
| Decision Date | 1983-06-08 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ANA-CHECK  73430026  1281042 Dead/Cancelled | Diagnostic Technology Inc. 1983-06-13 |