UNICAP GLIADIN IGA ASSAY— 510(k) K982533

Name: FDA 510(k) clearance K982533
Creator: U.S. Food and Drug Administration
Published: 1998-10-22

Substantially Equivalent

Pharmacia & Upjohn Co.

FDA 510(k) clearance K982533 for UNICAP GLIADIN IGA ASSAY, Substantially Equivalent on 1998-10-22. Applicant: Pharmacia & Upjohn Co.. Device class: 2.

Clearance details

Applicant: Pharmacia & Upjohn Co.
Product code: Code MST
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1998-07-20
Decision date: 1998-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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