The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Thyroxine Reagent.
| Device ID | K971203 |
| 510k Number | K971203 |
| Device Name: | SYNCHRON SYSTEMS THYROXINE REAGENT |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| 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 | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-01 |
| Decision Date | 1997-05-16 |
| Summary: | summary |