Panels › Clinical Chemistry › Product code MQM · Class 1
Bilirubin (Total And Unbound) In The Neonate Test System
Regulation 862.1113
0510(k)s in 12 months (17 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in MQM
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 1 | 4 |
| Draeger Medical Systems, Inc. | 1 | 2 |
| Chromatics Color Sciences Intl., Inc. | 2 | 0 |
| Radiometer Medical Aps | 2 | 0 |
| Respironics, Inc. | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Air-Shields, Inc. | 1 | 0 |
| Draeger Medical Infant Care, Inc. | 1 | 0 |
| Hill-Rom Air-Shields | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2018 | Draeger Medical Systems, Inc. Draeger Jaundice Meter JM-105
The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infant Terminated |
MQM | K133175 |
| Jun 7, 2018 | Draeger Medical Systems, Inc. Draeger Jaundice Meter JM-103
The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infan Terminated |
MQM | K042522 |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524.
The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testin Terminated |
MQM | K073537 |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179.
The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testin Terminated |
MQM | K073537 |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306.
The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory enviro Terminated |
MQM | K113216 |
| Mar 6, 2015 | Siemens Healthcare Diagnostics Inc RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784.
These systems are intended for near-pa Terminated |
MQM | K110277 |
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