The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Lx Systems Transferrin (trfn) Reagent.
Device ID | K971958 |
510k Number | K971958 |
Device Name: | SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT |
Classification | Transferrin, Antigen, Antiserum, Control |
Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
Contact | Lucinda Stockert |
Correspondent | Lucinda Stockert 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 | 1997-05-28 |
Decision Date | 1997-08-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590575069 | K971958 | 000 |