NRBC-CHEX FOR ADVIA— 510(k) K080016

Substantially Equivalent

Streck

FDA 510(k) clearance K080016 for NRBC-CHEX FOR ADVIA, Substantially Equivalent on 2008-02-05. Applicant: Streck. Device class: 2.

Clearance details

Applicant: Streck
Product code: Code GJR
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2008-01-03
Decision date: 2008-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, 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.