QUANTA LITE ENA 5 ELISA KIT— 510(k) K943076

Name: FDA 510(k) clearance K943076
Creator: U.S. Food and Drug Administration
Published: 1994-10-25

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K943076 for QUANTA LITE ENA 5 ELISA KIT, Substantially Equivalent on 1994-10-25. 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: 1994-06-28
Decision date: 1994-10-25
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.