QUANTA LITE RF IGM— 510(k) K971614

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K971614 for QUANTA LITE RF IGM, Substantially Equivalent on 1997-06-20. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1997-05-02
Decision date: 1997-06-20
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.