| K-number | K031296 |
| Device name | LIQUI-HEME GLYCO A1C ASSAY |
| Applicant | Biodiagnostic Intl |
| Product code | LCP |
| Device class | Class II |
| Decision date | Oct 15, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 864.7470 |
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