K062948

Substantially Equivalent

SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B

Applicant
Cepheid
Product code
NJR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
Download summary PDF View on FDA.gov ↗

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