The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Aso-check.
| Device ID | K831464 |
| 510k Number | K831464 |
| Device Name: | ASO-CHECK |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-06 |
| Decision Date | 1983-06-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ASO-CHECK 73430027 1281043 Dead/Cancelled |
Diagnostic Technology Inc. 1983-06-13 |