The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Iron (fe)/total Iron Binding Capacity Reagents.
| Device ID | K960485 |
| 510k Number | K960485 |
| Device Name: | SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590233365 | K960485 | 000 |
| 15099590233105 | K960485 | 000 |
| 15099590228729 | K960485 | 000 |
| 15099590222932 | K960485 | 000 |