QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA— 510(k) K010558

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K010558 for QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA, Substantially Equivalent on 2001-04-03. Applicant: Inova Diagnostics, Inc..

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code MLE
Advisory panel: Immunology
Date received: 2001-02-26
Decision date: 2001-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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