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U.S. Department of Health and Human Services

Product Classification
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Device analyzer, chromosome, automated
Regulation Description Automated cell-locating device.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeLNJ
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 864.5260
Device Class 2
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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