Portrait GBS Assay— 510(k) K143312

Substantially Equivalent

Great Basin Corporation

FDA 510(k) clearance K143312 for Portrait GBS Assay, Substantially Equivalent on 2015-04-21. Applicant: Great Basin Corporation.

Clearance details

Applicant
Great Basin Corporation
Product code
Code NJR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Salt Lake City, UT, US
Download summary PDFView on FDA.gov ↗

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