K981084

Substantially Equivalent

URISCREEN

Applicant: Diatech Diagnostics,Inc.
Product code: JXA
Advisory panel: Microbiology
Date received: 1998-03-25
Decision date: 1998-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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