The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Testcorp Aso.
| Device ID | K831363 |
| 510k Number | K831363 |
| Device Name: | TESTCORP ASO |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | CATHETER TECHNOLOGY CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-26 |
| Decision Date | 1983-05-16 |