510(k) K810848
K810848 is an FDA 510(k) premarket notification submitted by Cytochem, Inc. for the device "CYTOBUCKET MODEL 1024". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code IFB (Cytocentrifuge), a Class I device regulated under 21 CFR 864.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- March 27, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cytocentrifuge
- Device Class
- Class I
- Regulation Number
- 864.3300
- Review Panel
- PA
- Submission Type