The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc 600i Synchron Access Clinical System.
| Device ID | K060256 |
| 510k Number | K060256 |
| Device Name: | UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM |
| Classification | Hexokinase, Glucose |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD. Brea, CA 92622 |
| Contact | Mary Beth Tang |
| Correspondent | Mary Beth Tang BECKMAN COULTER, INC. 200 S. KRAEMER BLVD. Brea, CA 92622 |
| Product Code | CFR |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGN |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHL |
| Subsequent Product Code | DCK |
| Subsequent Product Code | DFT |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JHI |
| Subsequent Product Code | JIY |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| Subsequent Product Code | JMG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCD |
| Subsequent Product Code | LCP |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-01 |
| Decision Date | 2006-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590233082 | K060256 | 000 |