FIRST RESPONSE OVULATION PREDICTOR TEST
Device Facts
| Record ID | K953581 |
|---|---|
| Device Name | FIRST RESPONSE OVULATION PREDICTOR TEST |
| Applicant | Armkel, LLC |
| Product Code | CEP · Clinical Chemistry |
| Decision Date | Oct 3, 1995 |
| 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.
