Beckman Coulter, Inc. · Class I · Cleared Sep 16, 2004
| K-number | K042195 |
| Device name | SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 |
| Applicant | Beckman Coulter, Inc. |
| Product code | LBS |
| Device class | Class I |
| Decision date | Sep 16, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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