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U.S. Department of Health and Human Services

Product Classification
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Device tissue processing kit
Definition For the preparation of human tissue specimens for frozen sectioning and histological examination.
Physical State Freezing device, heat sink and a chuck with embeddign mold
Technical Method The freezing device and heat sink are housed in an insulated box and the entire kit would be used at the dissecting bench, allowing users to freeze the sample for future cutting or slicing.
Target Area Any human tissue
Review Panel Pathology
Product CodePFU
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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