Product code IFB— Pathology

CYTO-TEK CENTRIFUGE

Classification name: Cytocentrifuge
Device class: Class 1
Regulation: 21 CFR 864.3300
Advisory panel: Pathology
Total cleared: 3
First cleared: 1979-11-30
Most recent: 1985-06-10

Market context for product code IFB

FDA has cleared 3 devices under product code IFB between 1979 and 1985, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19851 clearance
19811 clearance
19791 clearance

Top applicants under product code IFB

Robert C. Leif, Ph.D.1 clearance
Miles Laboratories, Inc.1 clearance
Cytochem, Inc.1 clearance

Recent clearances under product code IFB

K852117 — CYTO-TEK CENTRIFUGEMiles Laboratories, Inc.·1985-06-10
K810848 — CYTOBUCKET MODEL 1024Cytochem, Inc.·1981-04-23
K792032 — LEIF CENTRIFUGAL CYTOLOGY BUCKETRobert C. Leif, Ph.D.·1979-11-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.