The following data is part of a premarket notification filed by Icl Scientific with the FDA for Antistreptolysin (aso) Latex Slide Test.
| Device ID | K790831 |
| 510k Number | K790831 |
| Device Name: | ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | ICL SCIENTIFIC 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 | 1979-04-30 |
| Decision Date | 1979-06-15 |