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U.S. Department of Health and Human Services

Product Classification

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Device tubes, vacuum sample, with anticoagulant
Regulation Description Blood specimen collection device.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeGIM
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons