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510(k) K973897

DHEA-S by Kmi Diagnostics, Inc. — Product Code JKC

K973897 is an FDA 510(k) premarket notification submitted by Kmi Diagnostics, Inc. for the device "DHEA-S". The FDA issued a decision of Substantially Equivalent on November 13, 1997. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Kmi Diagnostics, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1997
Date Received
October 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device Class
Class I
Regulation Number
862.1245
Review Panel
CH
Submission Type

Other clearances by Kmi Diagnostics, Inc.

  • K010790 — CORTISOL LIA (January 29, 2002)
  • K990073 — CALCITONIN (May 11, 1999)
  • K973900 — TESTOTERONE ELISA (February 24, 1998)
  • K973901 — 17 B-ESTRADIOL (ELISA) (November 24, 1997)
  • K973898 — PROGESTERONE ELISA (November 13, 1997)

Other clearances for product code JKC

  • K040181 — ACCESS DHEA-S REAGENT ASSAY (March 24, 2004)
  • K003174 — ELECSYS DHEA-S (January 17, 2001)
  • K962895 — DSL DHEA-S-7 (September 10, 1996)
  • K955114 — DSL AACTIVE DHEA EIA KIT (February 23, 1996)
  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K935014 — ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) (May 9, 1994)
  • K935806 — IMMULITE DHEA-S04 (April 26, 1994)
  • K935469 — SYNELISA DHEA-SULFATE (March 22, 1994)
  • K931601 — CHEMILUMINESCENCE DHEA-S IMMUNOASSAY (July 27, 1993)

FDA data resources