The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Hcg-check.
| Device ID | K831466 | 
| 510k Number | K831466 | 
| Device Name: | HCG-CHECK | 
| Classification | Agglutination Method, Human Chorionic Gonadotropin | 
| Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | JHJ | 
| CFR Regulation Number | 862.1155 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1983-05-06 | 
| Decision Date | 1983-06-22 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HCG-CHECK  73430025  1283798 Dead/Cancelled | Diagnostic Technology Inc. 1983-06-13 | 
|  HCG-CHECK  73430024  1290527 Dead/Cancelled | Diagnostic Technology Inc. 1983-06-13 |