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510(k) K792032

LEIF CENTRIFUGAL CYTOLOGY BUCKET by Robert C. Leif, Ph.D. — Product Code IFB

K792032 is an FDA 510(k) premarket notification submitted by Robert C. Leif, Ph.D. for the device "LEIF CENTRIFUGAL CYTOLOGY BUCKET". The FDA issued a decision of Substantially Equivalent on November 30, 1979. 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
November 30, 1979
Date Received
October 10, 1979
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

Other clearances for product code IFB

  • K852117 — CYTO-TEK CENTRIFUGE (June 10, 1985)
  • K810848 — CYTOBUCKET MODEL 1024 (April 23, 1981)

FDA data resources