JLP — Spectrophotometric Method, Pregnanediol Class I
FDA product code JLP covers "Spectrophotometric Method, Pregnanediol", a Class I medical device regulated under 21 CFR 862.1605. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- JLP
- Device Class
- Class I
- Regulation Number
- 862.1605
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K872843 | boots-celltech diagnostics | OVEIA (TM) DUAL ANALYTE | February 2, 1988 |