The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Transferrin Kit.
Device ID | K926272 |
510k Number | K926272 |
Device Name: | BECKMAN TRANSFERRIN KIT |
Classification | Transferrin, Antigen, Antiserum, Control |
Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Contact | William T Ryan |
Correspondent | William T Ryan BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Product Code | DDG |
CFR Regulation Number | 866.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-18 |
Decision Date | 1993-10-07 |