The following data is part of a premarket notification filed by Fujirebio America, Inc. with the FDA for Serodia Atg.
Device ID | K953066 |
510k Number | K953066 |
Device Name: | SERODIA ATG |
Classification | Thyroglobulin, Antigen, Antiserum, Control |
Applicant | FUJIREBIO AMERICA, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Contact | Robert Scjoff |
Correspondent | Robert Scjoff FUJIREBIO AMERICA, INC. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
Product Code | DDC |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-30 |
Decision Date | 1995-08-14 |