510(k) K971007— LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)

Substantially Equivalent

Mrl Diagnostics

Clearance details

Applicant: Mrl Diagnostics
Product code: Code LSR
Advisory panel: Microbiology
Date received: 1997-03-19
Decision date: 1998-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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