ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)— 510(k) K871994

Name: FDA 510(k) clearance K871994
Creator: U.S. Food and Drug Administration
Published: 1987-08-12

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K871994 for ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS), Substantially Equivalent on 1987-08-12. 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: 1987-05-26
Decision date: 1987-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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