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510(k) K973900

TESTOTERONE ELISA by Kmi Diagnostics, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
October 14, 1997
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 Kmi Diagnostics, Inc.

  • K010790 — CORTISOL LIA (January 29, 2002)
  • K990073 — CALCITONIN (May 11, 1999)
  • K973901 — 17 B-ESTRADIOL (ELISA) (November 24, 1997)
  • K973898 — PROGESTERONE ELISA (November 13, 1997)
  • K973897 — DHEA-S (November 13, 1997)

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