The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxc Synchron System Hdl Cholesterol Reagent(hdl),unicel Dxc Synchron System Hdl Calibrator.
| Device ID | K142985 |
| 510k Number | K142985 |
| Device Name: | UniCel DxC SYNCHRON System HDL Cholesterol Reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator |
| Classification | Calibrator, Secondary |
| Applicant | BECKMAN COULTER, INC. 250 S. KREAMER BOULEVARD Brea, CA 92821 |
| Contact | Eimear Carr |
| Correspondent | Eimear Carr BECKMAN COULTER, INC. 250 S. KREAMER BOULEVARD Brea, CA 92821 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2015-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590669706 | K142985 | 000 |
| 15099590193218 | K142985 | 000 |