DHEA-S— 510(k) K973897

Substantially Equivalent

Kmi Diagnostics, Inc.

FDA 510(k) clearance K973897 for DHEA-S, Substantially Equivalent on 1997-11-13. Applicant: Kmi Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Kmi Diagnostics, Inc.
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1997-10-14
Decision date: 1997-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JKC

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K955114 — DSL AACTIVE DHEA EIA KIT1996-02-23
K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY1995-05-15

More clearances from Kmi Diagnostics, Inc.

K010790 — CORTISOL LIA2002-01-29
K990073 — CALCITONIN1999-05-11
K973900 — TESTOTERONE ELISA1998-02-24
K973901 — 17 B-ESTRADIOL (ELISA)1997-11-24
K973898 — PROGESTERONE ELISA1997-11-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.