510(k) K922085
K922085 is an FDA 510(k) premarket notification submitted by Gen Trak, Inc. for the device "MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM". The FDA issued a decision of Substantially Equivalent on July 28, 1992. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Gen Trak, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1992
- Date Received
- May 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type