FLUORO-CEP Progesterone
FDA PMAFDA 510(k)Class III (US FDA PMA)
Identity
- Trade Name
- FLUORO-CEP (R) PROGESTERONE FDA PMA
- Generic Name
- KIT, ASSAY, PROGESTERONE RECEPTOR FDA PMA
Classification
- Advisory Committee
- Unknown FDA PMA
- FDA Decision
- SESE Substantially Equivalent FDA PMA
FLUORO-CEP Progesterone is a kit assay for progesterone receptor. It is designed for the detection and measurement of progesterone receptors in biological specimens.
The device is supplied as a diagnostic kit for use in laboratory settings. It has received FDA authorization via both 510(k) (K821060) and PMA (P900025) pathways, with a traditional clearance type and substantial equivalence determination.
Frequently asked questions
What type of device is FLUORO-CEP Progesterone?
FLUORO-CEP Progesterone is a kit assay for progesterone receptor, as defined by its generic name and device name in the specifications. It is intended for laboratory use to measure progesterone receptors in specimens.
Who manufactures FLUORO-CEP Progesterone and where are they located?
FLUORO-CEP Progesterone is manufactured by Zeus Scientific, Inc., with addresses listed in Mchenry, IL (803 N. Front St. Suite 3, postal code 60050) and another location at 200 Evans Way (zip 08876).
What regulatory authorizations does FLUORO-CEP Progesterone have?
FLUORO-CEP Progesterone has received both FDA 510(k) clearance (K821060) and FDA PMA approval (P900025), with a decision date of June 22, 1982, and a traditional clearance pathway based on substantial equivalence.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Premarket Approval (PMA) - FDA, FLUORO-CEP (R) PROGESTERONE (P900025) — FDA 510(k ..., ZEUS SCIENTIFIC LLC FDA Filings - FDA.report, Histochemical localization of estrogen and progesterone receptors ..., evaluation of a method. - Sage Journals
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K821060 | Class III | Active |
| FDA PMA | United States | FDA_PMA | P900025 | Class III | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (2)
- FDA PMA P900025 37 fields · synced Sep 18, 2026
- FDA 510(k) K821060 1 fields · synced May 18, 2026