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 |