LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET— 510(k) K994110

Name: FDA 510(k) clearance K994110
Creator: U.S. Food and Drug Administration
Published: 1999-12-21

Substantially Equivalent

Diasorin/American Standard Companies

FDA 510(k) clearance K994110 for LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET, Substantially Equivalent on 1999-12-21. Applicant: Diasorin/American Standard Companies. Device class: 2.

Clearance details

Applicant: Diasorin/American Standard Companies
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 1999-12-06
Decision date: 1999-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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