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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 Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1675
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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