QUANTA LITE ANA ELISA— 510(k) K991657

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K991657 for QUANTA LITE ANA ELISA, Substantially Equivalent on 1999-06-17. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1999-05-13
Decision date: 1999-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.