OPTIMATE IGA TEST— 510(k) K841815

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K841815 for OPTIMATE IGA TEST, Substantially Equivalent on 1984-06-01. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code CZN
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1984-05-01
Decision date: 1984-06-01
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.