Sigma Diagnostics, Inc. · Class II · Cleared Oct 26, 2001
| K-number | K012410 |
| Device name | INFINITY HBA KIT, MODELS 537-A, 537-B |
| Applicant | Sigma Diagnostics, Inc. |
| Product code | LCP |
| Device class | Class II |
| Decision date | Oct 26, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 864.7470 |
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