OSOM PREGNANCY TEST
Device Facts
| Record ID | K954178 |
|---|---|
| Device Name | OSOM PREGNANCY TEST |
| Applicant | Wyntek Diagnostics, Inc. |
| Product Code | LCX · Clinical Chemistry |
| Decision Date | Oct 23, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1155 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.
