The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Cx Pro Clinical Systems, Model Cx4 Pro, Cx5 Pro, Cx7 Pro, Cx9 Pro.
| Device ID | K011465 |
| 510k Number | K011465 |
| Device Name: | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO |
| Classification | Colorimetry, Acetaminophen |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Mary B Tang |
| Correspondent | Mary B Tang BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | LDP |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CFJ |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHI |
| Subsequent Product Code | CHW |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CJW |
| Subsequent Product Code | CJY |
| Subsequent Product Code | CKA |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-14 |
| Decision Date | 2001-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590625719 | K011465 | 000 |
| 15099590625610 | K011465 | 000 |
| 15099590575274 | K011465 | 000 |
| 15099590225322 | K011465 | 000 |