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

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..

Clearance details

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

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