VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
Device Facts
| Record ID | K964982 |
|---|---|
| Device Name | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | CEP · Clinical Chemistry |
| Decision Date | Feb 20, 1997 |
| 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.
