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U.S. Department of Health and Human Services

Product Classification

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Device tray, blood collection
Regulation Description Blood specimen collection device.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeGJE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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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