Instrumentation Laboratory CO · Class II · Cleared Mar 13, 2009
| K-number | K083518 |
| Device name | ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS |
| Applicant | Instrumentation Laboratory CO |
| Product code | JPA |
| Device class | Class II |
| Decision date | Mar 13, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 864.5425 |
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