SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B— 510(k) K062948

Name: FDA 510(k) clearance K062948
Creator: U.S. Food and Drug Administration
Published: 2006-12-08

Substantially Equivalent

Cepheid

FDA 510(k) clearance K062948 for SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B, Substantially Equivalent on 2006-12-08. 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: 2006-09-28
Decision date: 2006-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.