PROGESTERONE DIRECT RIA KIT (125I)— 510(k) K811907

Name: FDA 510(k) clearance K811907
Creator: U.S. Food and Drug Administration
Published: 1981-07-23

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K811907 for PROGESTERONE DIRECT RIA KIT (125I), Substantially Equivalent on 1981-07-23. Applicant: Immunalysis Corporation. Device class: 1.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code JLS
Device class: Class 1
Regulation: 21 CFR 862.1620
Advisory panel: Clinical Chemistry
Date received: 1981-07-01
Decision date: 1981-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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