ELECSYS DHEA-S— 510(k) K003174

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003174 for ELECSYS DHEA-S, Substantially Equivalent on 2001-01-17. Applicant: Roche Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 2000-10-10
Decision date: 2001-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JKC

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K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY1995-05-15

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