Gds Diagnostics · Class I · Cleared Mar 4, 1991
| K-number | K910108 |
| Device name | GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED |
| Applicant | Gds Diagnostics |
| Product code | JIN |
| Device class | Class I |
| Decision date | Mar 4, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 862.1435 |
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