The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Lx Systems Complement C3 (c3) Reagent, Synchron Lx Systems Complement C4 (c4) Reagent, Synchron Lx Systems Cali.
Device ID | K032035 |
510k Number | K032035 |
Device Name: | SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI |
Classification | Complement C3, Antigen, Antiserum, Control |
Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
Contact | Kim Walker |
Correspondent | Kim Walker BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
Product Code | CZW |
Subsequent Product Code | DBI |
Subsequent Product Code | JIT |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-01 |
Decision Date | 2003-08-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590233389 | K032035 | 000 |
15099590229733 | K032035 | 000 |
15099590229726 | K032035 | 000 |