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U.S. Department of Health and Human Services

Product Classification

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Device test, time, partial thromboplastin
Regulation Description Partial thromboplastin time tests.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGGW
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.7925
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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