HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM— 510(k) K926114

Name: FDA 510(k) clearance K926114
Creator: U.S. Food and Drug Administration
Published: 1993-05-20

Substantially Equivalent

Tissue Culture Biotec, Inc.

FDA 510(k) clearance K926114 for HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM, Substantially Equivalent on 1993-05-20. Applicant: Tissue Culture Biotec, Inc.. Device class: 2.

Clearance details

Applicant: Tissue Culture Biotec, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1992-12-03
Decision date: 1993-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bozeman, MT, US

Download summary PDF View on FDA.gov ↗

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