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510(k) K872076

CORNING DISPOSABLE ROLLER BOTTLES by Corning Medical & Scientific — Product Code KJB

K872076 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "CORNING DISPOSABLE ROLLER BOTTLES". The FDA issued a decision of Substantially Equivalent on June 15, 1987. The device falls under product code KJB (Apparatus, Roller), 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
June 15, 1987
Date Received
May 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Roller
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)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K854024 — CORNING MAGIC MAB HCG RADIOIMMUNOASSAY (November 26, 1985)
  • K853634 — CORNING CELL WELLS-MULTIPLE WELL PLATES (September 16, 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 KJB

  • K881466 — CELL-CULTURE SHAKER (April 18, 1988)
  • K852506 — BIOGLAS MICROCARRIER BEAD (July 12, 1985)

FDA data resources