MULTIPLE AUTO ANTIBODY TEST— 510(k) K791996

Name: FDA 510(k) clearance K791996
Creator: U.S. Food and Drug Administration
Published: 1980-01-16

Substantially Equivalent

Meda Stat Diagnostics, Inc.

FDA 510(k) clearance K791996 for MULTIPLE AUTO ANTIBODY TEST, Substantially Equivalent on 1980-01-16. Applicant: Meda Stat Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Meda Stat Diagnostics, Inc.
Product code: Code DBL
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1979-10-03
Decision date: 1980-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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