QUANTA LITE REBELLA IGG— 510(k) K971304

Name: FDA 510(k) clearance K971304
Creator: U.S. Food and Drug Administration
Published: 1998-01-02

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K971304 for QUANTA LITE REBELLA IGG, Substantially Equivalent on 1998-01-02. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1997-04-08
Decision date: 1998-01-02
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.