SPARTAN RX CYP2C19 TEST SYSTEM— 510(k) K123891

Name: FDA 510(k) clearance K123891
Creator: U.S. Food and Drug Administration
Published: 2013-08-12

Substantially Equivalent

Spartan Bioscience, Inc.

FDA 510(k) clearance K123891 for SPARTAN RX CYP2C19 TEST SYSTEM, Substantially Equivalent on 2013-08-12. Applicant: Spartan Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Spartan Bioscience, Inc.
Product code: Code NTI
Device class: Class 2
Regulation: 21 CFR 862.3360
Advisory panel: Clinical Toxicology
Date received: 2012-12-18
Decision date: 2013-08-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Redwood Shores, 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.