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 |