K842827

Substantially Equivalent

STREPTEX DIRECT A ZL14

Applicant
Wellcome Diagnostics
Product code
GTZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDF View on FDA.gov ↗

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