SHBG IRMA KIT— 510(k) K905247

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K905247 for SHBG IRMA KIT, Substantially Equivalent on 1991-01-17. Applicant: Ventrex Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1990-11-21
Decision date: 1991-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

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