The following data is part of a premarket notification filed by Monobind with the FDA for Hcg Ria Test System.
| Device ID | K854958 |
| 510k Number | K854958 |
| Device Name: | HCG RIA TEST SYSTEM |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | MONOBIND 729 W. 16TH STREET, C-4 Costa Mesa, CA 92627 |
| Contact | Michael R Falvo |
| Correspondent | Michael R Falvo MONOBIND 729 W. 16TH STREET, C-4 Costa Mesa, CA 92627 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-11 |
| Decision Date | 1986-01-28 |