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

Substantially Equivalent

Inova Diagnostics, Inc.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LSR
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.