CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE— 510(k) K914850

Name: FDA 510(k) clearance K914850
Creator: U.S. Food and Drug Administration
Published: 1991-12-09

Substantially Equivalent

Mast Immunosystems

FDA 510(k) clearance K914850 for CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE, Substantially Equivalent on 1991-12-09. Applicant: Mast Immunosystems. Device class: 2.

Clearance details

Applicant: Mast Immunosystems
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1991-10-28
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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