SHBG IRMA KIT— 510(k) K861679

Substantially Equivalent

Farmos Group , Ltd.

FDA 510(k) clearance K861679 for SHBG IRMA KIT, Substantially Equivalent on 1987-03-13. Applicant: Farmos Group , Ltd.. Device class: 1.

Clearance details

Applicant: Farmos Group , Ltd.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1986-05-01
Decision date: 1987-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.