XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)— 510(k) K121539

Name: FDA 510(k) clearance K121539
Creator: U.S. Food and Drug Administration
Published: 2012-11-02

Substantially Equivalent

Cepheid

FDA 510(k) clearance K121539 for XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX), Substantially Equivalent on 2012-11-02. Applicant: Cepheid. Device class: 1.

Clearance details

Applicant: Cepheid
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2012-05-24
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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