ANTI-NDNA ANTIBODY TEST KIT— 510(k) K864275

Name: FDA 510(k) clearance K864275
Creator: U.S. Food and Drug Administration
Published: 1986-12-15

Substantially Equivalent

Cappel Diagnostics, Inc.

FDA 510(k) clearance K864275 for ANTI-NDNA ANTIBODY TEST KIT, Substantially Equivalent on 1986-12-15. Applicant: Cappel Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Cappel Diagnostics, Inc.
Product code: Code KTL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1986-10-29
Decision date: 1986-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davis, CA, US

Download summary PDF View on FDA.gov ↗

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