QUANTA LITE LYME IGG ELISA— 510(k) K984222

Name: FDA 510(k) clearance K984222
Creator: U.S. Food and Drug Administration
Published: 1999-04-15

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K984222 for QUANTA LITE LYME IGG ELISA, Substantially Equivalent on 1999-04-15. 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: 1998-11-25
Decision date: 1999-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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