Cytoprep Inc. Est.
LI Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Cytoprep Ref K983181
What Cytoprep Inc. Est. makes
Cytoprep Inc. manufactures the CYTOPREP device, a medical instrument designed for cytological sample preparation, enabling precise cell collection and slide processing for diagnostic pathology.
The CYTOPREP device is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Cytoprep Inc. manufacture?
Cytoprep Inc. specializes in the CYTOPREP device, which is a medical instrument used for preparing cytological samples. This device helps in collecting cells and processing them onto slides, making it essential for diagnostic pathology procedures.
Where is Cytoprep Inc. based?
Cytoprep Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach.
How are Cytoprep Inc.’s devices classified under FDA regulations?
The CYTOPREP device is classified as a Class II medical device by the FDA. This classification is determined based on the device’s intended use and risk level, requiring specific regulatory controls to ensure safety and effectiveness.
Which regulatory registries or pathways list Cytoprep Inc.’s devices?
The CYTOPREP device is listed via the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to a legally marketed predicate device, demonstrating that they meet the same performance standards.
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