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510(k) K833406

IMMOPHASE D-TE 3 RADIOIMMUNOASSAY by Corning Medical & Scientific — Product Code CGF

K833406 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "IMMOPHASE D-TE 3 RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 24, 1984. The device falls under product code CGF (Radioimmunoassay, Estrone), a Class I device regulated under 21 CFR 862.1280. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1984
Date Received
September 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estrone
Device Class
Class I
Regulation Number
862.1280
Review Panel
CH
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)
  • 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)

Other clearances for product code CGF

  • K970915 — DSL ESTRONE-SULFATE RIA (May 16, 1997)
  • K935013 — DSL ESTRONE (DSL 8700) (June 16, 1994)
  • K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (January 9, 1987)

FDA data resources