The following data is part of a premarket notification filed by Biologics Intl., Inc. with the FDA for Bi-aso Slide Test.
| Device ID | K812060 |
| 510k Number | K812060 |
| Device Name: | BI-ASO SLIDE TEST |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | BIOLOGICS INTL., 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 | 1981-07-21 |
| Decision Date | 1981-08-13 |