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 |