The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Direct Ldl Chloesterol Reagent And Calibrator.
| Device ID | K014103 |
| 510k Number | K014103 |
| Device Name: | SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Mary Beth Tang |
| Correspondent | Mary Beth Tang BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-13 |
| Decision Date | 2002-01-28 |
| Summary: | summary |