Helena Laboratories · Class II · Cleared Dec 28, 1992
| K-number | K925801 |
| Device name | REP E-Z CK-30 ISOENZYME KIT |
| Applicant | Helena Laboratories |
| Product code | CGS |
| Device class | Class II |
| Decision date | Dec 28, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 862.1215 |
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