Helena Laboratories · Class II · Cleared Jul 14, 1980
| K-number | K801318 |
| Device name | HELENA ULTRA SENSITIVE CPK REAGENT/DILUE |
| Applicant | Helena Laboratories |
| Product code | JHX |
| Device class | Class II |
| Decision date | Jul 14, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 862.1215 |
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