510(k) K911590— IMMUNOWELL BORRELIA (LYME)TEST

Substantially Equivalent

General Biometrics, Inc.

Clearance details

Applicant: General Biometrics, Inc.
Product code: Code LSR
Advisory panel: Microbiology
Date received: 1991-04-09
Decision date: 1991-12-20
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.