The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Trf.
Device ID | K983167 |
510k Number | K983167 |
Device Name: | TRF |
Classification | Transferrin, Antigen, Antiserum, Control |
Applicant | ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
Contact | Linda Morris |
Correspondent | Linda Morris ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038 |
Product Code | DDG |
CFR Regulation Number | 866.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-10 |
Decision Date | 1998-11-04 |