Diagnostic Specialties · Class I · Cleared Sep 2, 1997
| K-number | K971458 |
| Device name | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT |
| Applicant | Diagnostic Specialties |
| Product code | JIQ |
| Device class | Class I |
| Decision date | Sep 2, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 862.1645 |
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