NGE · Test, Luteinizing Hormone (Lh), Over The Counter
Clinical Chemistry · 21 CFR 862.1485 · Class 1
Overview
| Product Code | NGE |
|---|---|
| Device Name | Test, Luteinizing Hormone (Lh), Over The Counter |
| Regulation | 21 CFR 862.1485 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020808 | FERTILITE OV | Pheromone Sciences Corp. | Sep 23, 2002 | SESE |
| K990223 | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | Feb 24, 1999 | SESE |
| K981207 | CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | Oct 28, 1998 | SESE |
| K973860 | OVULON MONITOR | Conception Technology, Inc. | Jan 7, 1998 | SESE |
| K863121 | PEAK OVULATION PREDICTOR | Micron Technology, Inc. | Oct 14, 1986 | SESE |
| K850579 | CUE FERTILITY MONITOR | Zetek, Inc. | Mar 22, 1985 | SESE |
Top Applicants
- Unipath , Ltd. — 2 clearances
- Conception Technology, Inc. — 1 clearance
- Micron Technology, Inc. — 1 clearance
- Pheromone Sciences Corp. — 1 clearance
- Zetek, Inc. — 1 clearance
