Cleared Traditional

DHEA-S

K973897 · Kmi Diagnostics, Inc. · Chemistry
Nov 1997
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K973897 is an FDA 510(k) clearance for the DHEA-S, a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I — General Controls, product code JKC), submitted by Kmi Diagnostics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 13, 1997, 30 days after receiving the submission on October 14, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1245.

Submission Details

510(k) Number K973897 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1997
Decision Date November 13, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1245

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