Helena Laboratories · Class I · Cleared May 12, 1982
| K-number | K820772 |
| Device name | FETAL-TEK CONTROL (IMMATURE/BORDERLINE) |
| Applicant | Helena Laboratories |
| Product code | JJX |
| Device class | Class I |
| Decision date | May 12, 1982 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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