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 |