TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
Device Facts
| Record ID | K860984 |
|---|---|
| Device Name | TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT |
| Applicant | Hybritech, Inc. |
| Product Code | CEP · Clinical Chemistry |
| Decision Date | Apr 29, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1485 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.
