BILICHEK NON-INVASIVE BILIRUBIN ANALYZER— 510(k) K983071

Name: FDA 510(k) clearance K983071
Creator: U.S. Food and Drug Administration
Published: 1999-03-04

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K983071 for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER, Substantially Equivalent on 1999-03-04. Applicant: Respironics, Inc.. Device class: 1.

Clearance details

Applicant: Respironics, Inc.
Product code: Code MQM
Device class: Class 1
Regulation: 21 CFR 862.1113
Advisory panel: Clinical Chemistry
Date received: 1998-09-02
Decision date: 1999-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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