The following data is part of a premarket notification filed by Hillside Acres, Inc. with the FDA for Control Serums For Nontreponemal Test.
| Device ID | K810119 |
| 510k Number | K810119 |
| Device Name: | CONTROL SERUMS FOR NONTREPONEMAL TEST |
| Classification | Antisera, Control For Nontreponemal Tests |
| Applicant | HILLSIDE ACRES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMP |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-16 |
| Decision Date | 1981-02-09 |