Stanbio Laboratory · Class I · Cleared Mar 10, 2004
| K-number | K032932 |
| Device name | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR |
| Applicant | Stanbio Laboratory |
| Product code | LBS |
| Device class | Class I |
| Decision date | Mar 10, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 862.1475 |
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