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510(k) K875122

DISPOSABLE STERILE SYRINGE FILTERS by Corning Medical & Scientific — Product Code KET

K875122 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "DISPOSABLE STERILE SYRINGE FILTERS". The FDA issued a decision of Substantially Equivalent on January 12, 1988. The device falls under product code KET (Filters, Cell Collection, Tissue Processing), a Class I device regulated under 21 CFR 864.3010. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filters, Cell Collection, Tissue Processing
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Corning Medical & Scientific

  • 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)
  • 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 KET

  • K870196 — PCTE MICROPOROUS MEMBRANE FILTER (May 12, 1987)
  • K844671 — CORNING DISPOSAL STERILE FILTER SYSTEM-NYLON (February 25, 1985)
  • K840556 — DISPOSABLE SYRINGE FILTERS (March 5, 1984)
  • K792633 — STERILIZATION PROCESS/OUTERWRAP (January 11, 1980)

FDA data resources