The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Immuno/aso.
| Device ID | K894780 |
| 510k Number | K894780 |
| Device Name: | IMMUNO/ASO |
| Classification | Antistreptolysin - Titer/streptolysin O Reagent |
| Applicant | IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Kenneth Kupits |
| Correspondent | Kenneth Kupits IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | GTQ |
| CFR Regulation Number | 866.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-27 |
| Decision Date | 1989-10-16 |