MQM · Class I · 21 CFR 862.1113

FDA Product Code MQM: Bilirubin (total And Unbound) In The Neonate Test System

Leading manufacturers include Respironics, Inc., Roche Diagnostics Corp. and Instrumentation Laboratory CO.

17
Total
17
Cleared
212d
Avg days
1992
Since

FDA 510(k) Cleared Bilirubin (total And Unbound) In The Neonate Test System Devices (Product Code MQM)

17 devices
1–17 of 17
Cleared May 14, 2004
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174
Roche Diagnostics Corp.
Chemistry · 109d
Cleared Mar 19, 2001
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052
Respironics, Inc.
Chemistry · 70d
Cleared Mar 04, 1999
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071
Respironics, Inc.
Chemistry · 183d
Cleared Sep 23, 1998
NBIL
K983134
Abbott Laboratories
Chemistry · 15d
Cleared May 06, 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
K980646
Instrumentation Laboratory CO
Chemistry · 76d

About Product Code MQM - Regulatory Context