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510(k) K853634

CORNING CELL WELLS-MULTIPLE WELL PLATES by Corning Medical & Scientific — Product Code KIZ

K853634 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "CORNING CELL WELLS-MULTIPLE WELL PLATES". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code KIZ (Dish, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
August 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dish, Tissue Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type

Other clearances by Corning Medical & Scientific

  • K875122 — DISPOSABLE STERILE SYRINGE FILTERS (January 12, 1988)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K872076 — CORNING DISPOSABLE ROLLER BOTTLES (June 15, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K854024 — CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (November 26, 1985)
  • K851939 — CORNING CERTAIN -ISE (June 14, 1985)
  • K851329 — MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA (June 13, 1985)
  • K850806 — CORNING BLOOD COLLECTION CAPILLARY TUBES (March 25, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)
  • K844671 — CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (February 25, 1985)

Other clearances for product code KIZ

  • K890542 — MULTIWELL CULTURE PLATE INSERTS (February 14, 1989)
  • K873891 — TISSUE CULTURE DISHES (November 25, 1987)
  • K871483 — TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES (April 29, 1987)
  • K854724 — CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE (December 13, 1985)
  • K821687 — REMOVAWELL TISSUE CULTURE PLATE W/LID (June 24, 1982)
  • K790958 — 120 WELL HISTO-PLATE (June 28, 1979)
  • K781792 — PRESSURIZER, EXETER CEMENT (February 8, 1979)

FDA data resources