MONO-LATEX (TM) SLIDE TEST— 510(k) K862008

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K862008 for MONO-LATEX (TM) SLIDE TEST, Substantially Equivalent on 1986-07-03. Applicant: Armkel, LLC. Device class: 2.

Clearance details

Applicant: Armkel, LLC
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1986-05-27
Decision date: 1986-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranbury, NJ, 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.