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510(k) K833406

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

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

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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)