Cytocentrifuge

FDA product code IFB · Class I (low risk) · 21 CFR 864.3300 · Pathology

3510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K852117Cyto-Tek CentrifugeIFB · Traditional Miles Laboratories, Inc.06/10/1985SE
K810848Cytobucket Model 1024IFB · Traditional Cytochem, Inc.04/23/1981SE
K792032Leif Centrifugal Cytology BucketIFB · Traditional Robert C. Leif, Ph.D.11/30/1979SE

Recalls

RecallProductFirmInitiated
Z-2749-2018 Class IIIEZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown…Mislabeled product Richard-Allan Scientific Company06/04/2018Terminated
Z-1367-2013 Class IISLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass…Separation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1… Separation Technology, Inc.03/13/2013Terminated