APO B., IMMUNOTURBIDIMETRIC ASSAY— 510(k) K864228

Name: FDA 510(k) clearance K864228
Creator: U.S. Food and Drug Administration
Published: 1987-03-12

Substantially Equivalent

Intl. Diagnostic Laboratories, Ltd.

FDA 510(k) clearance K864228 for APO B., IMMUNOTURBIDIMETRIC ASSAY, Substantially Equivalent on 1987-03-12. Applicant: Intl. Diagnostic Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Intl. Diagnostic Laboratories, Ltd.
Product code: Code MSJ
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1986-10-28
Decision date: 1987-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

Download summary PDF View on FDA.gov ↗

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