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510(k) K014120

TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) by Diagnostics Biochem Canada, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2002
Date Received
December 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

Other clearances by Diagnostics Biochem Canada, Inc.

  • K030730 — FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (August 18, 2003)
  • K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (January 9, 1987)
  • K832297 — HYDROXYPROGESTERONE-17 (September 1, 1983)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)
  • K781310 — HUMAN CHORIONIC GONADO.-BETA RIA KIT (August 31, 1978)

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