The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Technicon Immuno 1 System Total Triiodothyronine.
Device ID | K923258 |
510k Number | K923258 |
Device Name: | TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Contact | Robert L Habig |
Correspondent | Robert L Habig HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-02 |
Decision Date | 1992-09-23 |