SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M— 510(k) K850586

Name: FDA 510(k) clearance K850586
Creator: U.S. Food and Drug Administration
Published: 1985-03-14

Substantially Equivalent

Applications Lab

FDA 510(k) clearance K850586 for SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M, Substantially Equivalent on 1985-03-14. Applicant: Applications Lab. Device class: 2.

Clearance details

Applicant: Applications Lab
Product code: Code DAO
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1985-02-13
Decision date: 1985-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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