RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER— 510(k) K010052

Name: FDA 510(k) clearance K010052
Creator: U.S. Food and Drug Administration
Published: 2001-03-19

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K010052 for RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER, Substantially Equivalent on 2001-03-19. 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: 2001-01-08
Decision date: 2001-03-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

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