The following data is part of a premarket notification filed by Monobind with the FDA for Thyroxine (t4) Coated Tube Ria.
| Device ID | K921935 |
| 510k Number | K921935 |
| Device Name: | THYROXINE (T4) COATED TUBE RIA |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | MONOBIND 729 W. 16TH STREET, C-4 Costa Mesa, CA 92627 |
| Contact | Frederick R Jerome |
| Correspondent | Frederick R Jerome MONOBIND 729 W. 16TH STREET, C-4 Costa Mesa, CA 92627 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-24 |
| Decision Date | 1992-07-07 |