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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2017 | K170882 | ABL90 FLEX, ABL90 FLEX PLUS Radiometer Medical Aps, DK | MQM |
| Nov 13, 2014 | K133175 | DRAEGER JAUNDICE METER JM-105 Draeger Medical Systems, Inc. | MQM |
| Nov 13, 2014 | K132691 | ABL90 FLEX Radiometer Medical Aps, DK | MQM |
| Aug 15, 2011 | K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN Siemens Healthcare Diagnostics | MQM |
| Jun 27, 2008 | K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 Siemens Medical Solutions Diagnostics | MQM |
| Jul 6, 2005 | K042522 | JAUNDICE METER, MODEL JM 103 Draeger Medical Infant Care, Inc. | MQM |
| May 14, 2004 | K040174 | BILIRUBIN ASSAY ON THE OMNI S ANALYZER Roche Diagnostics Corp. | MQM |
| Apr 1, 2003 | K021622 | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 Hill-Rom Air-Shields | MQM |
| Sep 13, 2001 | K001687 | COLORMATE TLC BILITEST SYSTEM Chromatics Color Sciences Intl., Inc. | MQM |
| Mar 19, 2001 | K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER Respironics, Inc. | MQM |
| Feb 4, 2000 | K994438 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER Spectrx, Inc. | MQM |
| Mar 4, 1999 | K983071 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER Respironics, Inc. | MQM |
| Sep 23, 1998 | K983134 | NBIL Abbott Laboratories | MQM |
| Sep 22, 1998 | K972309 | JM-102 JAUNDICE METER Air-Shields, Inc. | MQM |
| May 6, 1998 | K980646 | IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES Instrumentation Laboratory CO | MQM |
| Jul 24, 1997 | K964590 | COLORMATE III Chromatics Color Sciences Intl., Inc. | MQM |
| Aug 18, 1992 | K922770 | UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 Leica, Inc. | MQM |
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