Helena Laboratories · Class I · Cleared Jul 2, 1981
| K-number | K811777 |
| Device name | HELENA PLASMINOGEN QUIPLATE PROCEDURE |
| Applicant | Helena Laboratories |
| Product code | DDX |
| Device class | Class I |
| Decision date | Jul 2, 1981 |
| Decision | Substantially Equivalent |
| Regulation | 866.5715 |
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