QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA— 510(k) K003959

Name: FDA 510(k) clearance K003959
Creator: U.S. Food and Drug Administration
Published: 2001-01-22

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K003959 for QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA, Substantially Equivalent on 2001-01-22. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2000-12-21
Decision date: 2001-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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