RIANEN 3H
by Dupont Legal
PMA P800061
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800061 | Date16 Jan 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- KIT, ASSAY, ESTROGEN RECEPTOR
- PMA Number
- FDA Product Code
- LPJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 864.1860
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- APPR Approved
- PMA Supplement
- S010
Overview
AI-generated summary, 18 Sep 2026
RIANEN 3H is a Kit, Assay, Estrogen Receptor as defined by its generic name and device classification. It is designed for the detection and measurement of estrogen receptors in clinical chemistry applications.
The device was manufactured by Dupont Legal in Wilmington, DE, and received FDA PMA approval (P800061) on April 24, 1984, following submission on March 26, 1984. It is classified as a Class III device under regulation number 864.1860.
Other devices from Dupont Legal
Questions
AI-generated answers, 18 Sep 2026
What is the generic name of the RIANEN 3H device?
The generic name of the RIANEN 3H device is KIT, ASSAY, ESTROGEN RECEPTOR, as specified in the device data under the generic_name field.
When did the RIANEN 3H receive FDA approval?
The RIANEN 3H received FDA PMA approval on April 24, 1984, as indicated by the decision_date field in the device data.
What is the PMA number for the RIANEN 3H device?
The PMA number for the RIANEN 3H device is P800061, which is explicitly listed in the pma_number field of the specifications.