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510(k) K864966

ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE by Diagnostics Biochem Canada, Inc. — Product Code CGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1987
Date Received
December 22, 1986
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 Diagnostics Biochem Canada, Inc.

  • K030730 — FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (August 18, 2003)
  • K014120 — TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) (February 8, 2002)
  • K832297 — HYDROXYPROGESTERONE-17 (September 1, 1983)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)
  • K781310 — HUMAN CHORIONIC GONADO.-BETA RIA KIT (August 31, 1978)

Other clearances for product code CGF

  • K970915 — DSL ESTRONE-SULFATE RIA (May 16, 1997)
  • K935013 — DSL ESTRONE (DSL 8700) (June 16, 1994)
  • K833406 — IMMOPHASE D-TE 3 RADIOIMMUNOASSAY (January 24, 1984)