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510(k) K030730

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2003
Date Received
March 10, 2003
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.

  • K014120 — TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) (February 8, 2002)
  • 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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