JLP · Spectrophotometric Method, Pregnanediol
Clinical Chemistry · 21 CFR 862.1605 · Class 1
Overview
| Product Code | JLP |
|---|---|
| Device Name | Spectrophotometric Method, Pregnanediol |
| Regulation | 21 CFR 862.1605 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A pregnanediol test system is a device intended to measure pregnanediol (a major urinary metabolic product of progesterone) in urine. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872843 | OVEIA (TM) DUAL ANALYTE | Boots-Celltech Diagnostics, Inc. | Feb 2, 1988 | SESE |
Top Applicants
- Boots-Celltech Diagnostics, Inc. — 1 clearance
