The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Aso Sure.
| Device ID | K820785 |
| 510k Number | K820785 |
| Device Name: | ASO SURE |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | ANALYTICAL PRODUCTS, 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 | 1982-03-23 |
| Decision Date | 1982-04-08 |