ANA TEST KIT— 510(k) K864668

Substantially Equivalent

Val Tech Diagnostics, Inc.

FDA 510(k) clearance K864668 for ANA TEST KIT, Substantially Equivalent on 1987-03-12. Applicant: Val Tech Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Val Tech Diagnostics, Inc.
Product code
Code LKJ
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pittsburgh, PA, US
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