MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET— 510(k) K900625

Name: FDA 510(k) clearance K900625
Creator: U.S. Food and Drug Administration
Published: 1990-02-26

Substantially Equivalent

Armkel, LLC

FDA 510(k) clearance K900625 for MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET, Substantially Equivalent on 1990-02-26. 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: 1990-02-08
Decision date: 1990-02-26
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.