K032453

Substantially Equivalent

ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL

Applicant
Bionostics, Inc.
Product code
JJY
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Devens, MA, US
Download summary PDF View on FDA.gov ↗

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