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U.S. Department of Health and Human Services

Product Classification

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Device tubes, vials, systems, serum separators, blood collection
Regulation Description Blood specimen collection device.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeJKA
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 862.1675
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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