Atlas FDA

IFB

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Cytocentrifuge
Device class
Class I (low risk)
Regulation
21 CFR 864.3300
Medical specialty
Pathology
Adverse events (MAUDE)
1998: 3 · 2000: 2 · 2001: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CYTO-TEK CENTRIFUGE (K852117)Miles Laboratories, Inc.1985-06-10
CYTOBUCKET MODEL 1024 (K810848)Cytochem, Inc.1981-04-23
LEIF CENTRIFUGAL CYTOLOGY BUCKET (K792032)Robert C. Leif, Ph.D.1979-11-30

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Every clearance here is in the API, with alerts when new ones post.