ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST— 510(k) K880003

Name: FDA 510(k) clearance K880003
Creator: U.S. Food and Drug Administration
Published: 1988-03-11

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K880003 for ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST, Substantially Equivalent on 1988-03-11. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1988-01-04
Decision date: 1988-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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