The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus T3.
Device ID | K953160 |
510k Number | K953160 |
Device Name: | OPUS T3 |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Sheila Keady |
Correspondent | Sheila Keady BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-07 |
Decision Date | 1995-08-24 |