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U.S. Department of Health and Human Services

Product Classification
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Device centrifuge for preparation of cell concentrate and/or plasma concentrate
Regulation Description General purpose laboratory equipment labeled or promoted for a specific medical use.
Definition To prepare cell concentrate and/or plasma concentrate by separating cells through centrifugation. Contraindications - Labeling Warnings and Precautions: The safety and effectiveness of this device for in vivo indications for use has not been established.
Physical State Centrifuge, process disposable and system accessories
Technical Method Uses centrifugation to separate cells based on cell density
Target Area Bone marrow and peripheral blood asprirate
Regulation Medical Specialty Clinical Chemistry
Review Panel Hematology
Product CodeQBV
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(K) Exempt
Regulation Number 862.2050
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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