U.S. FDA Medical Device Roller Apparatus Requirements
FDA Medical Device Definition: Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.
FDA Roller Apparatus Label Requirements and Exceptions
FDA Roller Apparatus Import Information
FDA Roller Apparatus Detentions (Roller Apparatus Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Roller Apparatus Manufacturers (Roller Apparatus Suppliers)
- Roller Apparatus Distributors
- Roller Apparatus Processors
- Roller Apparatus Repackers
- Roller Apparatus Relabelers
- Roller Apparatus Exporters
- Roller Apparatus Importers
For more information about Roller Apparatus Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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