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. Device class: 1.

Clearance details

Applicant: Great Basin Corporation
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2014-11-18
Decision date: 2015-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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