Hybritech, Inc. · Class I · Cleared Apr 29, 1986
| K-number | K860984 |
| Device name | TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT |
| Applicant | Hybritech, Inc. |
| Product code | CEP |
| Device class | Class I |
| Decision date | Apr 29, 1986 |
| Decision | Substantially Equivalent |
| Regulation | 862.1485 |
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