TANGENT SYSTEM(TM) ANA PROFILE TEST KIT— 510(k) K871144

Name: FDA 510(k) clearance K871144
Creator: U.S. Food and Drug Administration
Published: 1987-04-29

Substantially Equivalent

Vitrotec Laboratories, Inc.

FDA 510(k) clearance K871144 for TANGENT SYSTEM(TM) ANA PROFILE TEST KIT, Substantially Equivalent on 1987-04-29. Applicant: Vitrotec Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Vitrotec Laboratories, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-03-23
Decision date: 1987-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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