510(k) K101911
K101911 is an FDA 510(k) premarket notification submitted by Cylex, Inc. for the device "IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY". The FDA issued a decision of Substantially Equivalent on October 18, 2010. The device falls under product code NID (Assay, Proliferation, In Vitro, T Lymphocyte), a Class II device regulated under 21 CFR 864.5220. Cylex, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2010
- Date Received
- July 9, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Proliferation, In Vitro, T Lymphocyte
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- IM
- Submission Type
A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient.