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FDA 510(k), K010052, RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
FDA 510(k), K010052, RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
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510(K) Number: K010052
Device Name: RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
Manufacturer: RESPIRONICS, INC.
Device Classification Name: bilirubin (total and unbound) in the neonate test system
Regulation Number: 862.1113
Classification Product Code: MQM
Date Received: 01/08/2001
Decision Date: 03/19/2001
Regulation Medical Specialty: Clinical Chemistry
Device Name: RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
Manufacturer: RESPIRONICS, INC.
Device Classification Name: bilirubin (total and unbound) in the neonate test system
Regulation Number: 862.1113
Classification Product Code: MQM
Date Received: 01/08/2001
Decision Date: 03/19/2001
Regulation Medical Specialty: Clinical Chemistry
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