Axis-Shield · Class II · Cleared Jun 9, 2000
| K-number | K001574 |
| Device name | DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 |
| Applicant | Axis-Shield |
| Product code | MID |
| Device class | Class II |
| Decision date | Jun 9, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 866.5660 |
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