K Number
DEN000008Device Name
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)Manufacturer
Date Cleared
2001-02-16
(59 days)
Product Code
Regulation Number
876.5885Type
Post-NSEPanel
GUReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
(a)
Identification. Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.(b)
Classification. Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”