ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY— 510(k) K843978

Name: FDA 510(k) clearance K843978
Creator: U.S. Food and Drug Administration
Published: 1984-12-18

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K843978 for ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY, Substantially Equivalent on 1984-12-18. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1984-10-11
Decision date: 1984-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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