QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT— 510(k) K994004

Name: FDA 510(k) clearance K994004
Creator: U.S. Food and Drug Administration
Published: 2000-01-27

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K994004 for QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT, Substantially Equivalent on 2000-01-27. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1999-11-24
Decision date: 2000-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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