Dhea-S

FDA 510(k) K973897 · Kmi Diagnostics, Inc.

Substantially Equivalent

510(k) numberK973897

Submission

Device name
Dhea-S
Applicant
Kmi Diagnostics, Inc.
Minneapolis, MN, US
Received
October 14, 1997
Decision date
November 13, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device class
Class I (low risk)
Regulation
21 CFR 862.1245
Specialty
Clinical Chemistry

Other 510(k)s with product code JKC

510(k)DeviceApplicantDecision
K040181Access Dhea-S Reagent AssayJKC · Abbreviated Beckman Coulter, Inc.03/24/2004SE
K003174Elecsys Dhea-SJKC · Traditional Roche Diagnostics Corp.01/17/2001SE
K962895DSL DHEA-S-7JKC · Traditional Diagnostic Systems Laboratories, Inc.09/10/1996SE
K955114DSL Aactive Dhea Eia KitJKC · Traditional Diagnostic Systems Laboratories, Inc.02/23/1996SE
K950524Nichols Institute Diagnostics Dhea-S Chemiluminescence ImmunoassayJKC · Traditional Nichols Institute05/15/1995SE
K942051SR1 Dhea-S Enzyme ImmunoassayJKC · Traditional Serono Diagnostics, Inc.07/13/1994SE
K935014Active Dehydroepiandrosterone (Dhea)(Dsl 9000)JKC · Traditional Diagnostic Systems Laboratories, Inc.05/09/1994SE
K935806Immulite DHEA-S04JKC · Traditional Diagnostic Products Corp.04/26/1994SE
K935469Synelisa Dhea-SulfateJKC · Traditional Elias U.S.A., Inc.03/22/1994SE
K931601Chemiluminescence Dhea-S ImmunoassayJKC · Traditional Nichols Institute07/27/1993SE

More from Nichols Institute

510(k)DeviceDecision
K010790Cortisol LiaCGR · Traditional 01/29/2002SE
K990073CalcitoninJKR · Traditional 05/11/1999SE
K973900Testoterone ElisaCDZ · Traditional 02/24/1998SE
K97390117 B-Estradiol (Elisa)CHP · Traditional 11/24/1997SE
K973898Progesterone ElisaJLS · Traditional 11/13/1997SE

Questions and answers

When was Dhea-S cleared by the FDA?

Dhea-S (K973897) received a 510(k) decision of Substantially Equivalent on November 13, 1997, 30 days after the submission was received.

What is the product code of K973897?

The FDA product code is JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), a Class I (low risk) device regulated under 21 CFR 862.1245.