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., Radiometer Medical Aps and Roche Diagnostics Corp..

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 Apr 28, 2017
ABL90 FLEX, ABL90 FLEX PLUS
K170882
Radiometer Medical Aps
Chemistry · 35d
Cleared Nov 13, 2014
ABL90 FLEX
K132691
Radiometer Medical Aps
Chemistry · 442d
Cleared Nov 13, 2014
DRAEGER JAUNDICE METER JM-105
K133175
Draeger Medical Systems, Inc.
Chemistry · 392d
Cleared Aug 15, 2011
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277
Siemens Healthcare Diagnostics
Chemistry · 196d
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 Sep 22, 1998
JM-102 JAUNDICE METER
K972309
Air-Shields, Inc.
Chemistry · 459d
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