DIRECT ESTRIOL RIA KIT— 510(k) K781546

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K781546 for DIRECT ESTRIOL RIA KIT, Substantially Equivalent on 1978-12-04. Applicant: Immunalysis Corporation. Device class: 1.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code CGI
Device class: Class 1
Regulation: 21 CFR 862.1265
Advisory panel: Clinical Chemistry
Date received: 1978-09-13
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.