Product code MQM
- Device name
- Bilirubin (Total And Unbound) In The Neonate Test System
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1113
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170882 | ABL90 FLEX, ABL90 FLEX PLUS | Radiometer Medical Aps | 2017-04-28 |
| K132691 | ABL90 FLEX | Radiometer Medical Aps | 2014-11-13 |
| K133175 | DRAEGER JAUNDICE METER JM-105 | Draeger Medical Systems, Inc. | 2014-11-13 |
| K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN | Siemens Healthcare Diagnostics | 2011-08-15 |
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | Siemens Medical Solutions Diagnostics | 2008-06-27 |
| K042522 | JAUNDICE METER, MODEL JM 103 | Draeger Medical Infant Care, Inc. | 2005-07-06 |
| K040174 | BILIRUBIN ASSAY ON THE OMNI S ANALYZER | Roche Diagnostics Corp. | 2004-05-14 |
| K021622 | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 | Hill-Rom Air-Shields | 2003-04-01 |
| K001687 | COLORMATE TLC BILITEST SYSTEM | Chromatics Color Sciences Intl., Inc. | 2001-09-13 |
| K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | Respironics, Inc. | 2001-03-19 |
| K994438 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Spectrx, Inc. | 2000-02-04 |
| K983071 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Respironics, Inc. | 1999-03-04 |
| K983134 | NBIL | Abbott Laboratories | 1998-09-23 |
| K972309 | JM-102 JAUNDICE METER | Air-Shields, Inc. | 1998-09-22 |
| K980646 | IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES | Instrumentation Laboratory CO | 1998-05-06 |
| K964590 | COLORMATE III | Chromatics Color Sciences Intl., Inc. | 1997-07-24 |
| K922770 | UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 | Leica, Inc. | 1992-08-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812559011136 | UNISTAT® Bilirubinometer Specimen Cuvettes | REICHERT, INC. | 2025-08-12 |
| 00380740167578 | ARCHITECT | ABBOTT IRELAND | 2024-08-15 |
| 00884838096578 | BiliChek | Philips Medical Systems Hsg | 2022-10-21 |
| 00630414286143 | RAPIDPoint® 500e Blood Gas System | Siemens Healthcare Diagnostics Inc. | 2020-04-15 |
| 00380740174972 | ARCHITECT | Abbott GmbH | 2020-04-12 |
| 00380740174965 | ARCHITECT | Abbott GmbH | 2020-04-12 |
| 05700699059178 | REF 905-917 ABL90 FLEX sBOX | Radiometer Medical ApS | 2018-09-21 |
| 05700699058027 | Disposable Waste Container D513 REF 905-802 | Radiometer Medical ApS | 2018-09-21 |
| 05700699055903 | Disposable Waste Container D512 REF 905-590 | Radiometer Medical ApS | 2018-09-21 |
| 08426950807568 | GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807827 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807766 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807544 | GEM Premier 5000 PAK BG/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807582 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807605 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807629 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807643 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807667 | GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807681 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807704 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807742 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 08426950807803 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST | INSTRUMENTATION LABORATORY COMPANY | 2018-01-24 |
| 00380740129040 | ARCHITECT | Abbott GmbH | 2016-12-31 |
| 00630414513072 | ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00380740011383 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740011369 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 05700693930909 | ABL90 FLEX Analyzer | Radiometer Medical ApS | 2016-09-01 |
| 05700693938004 | ABL800 FLEX | Radiometer Medical ApS | 2016-09-01 |
| 05700693938011 | ABL800 FLEX | Radiometer Medical ApS | 2016-09-01 |
| 05700699058348 | Accessories starter kit for ABL800 FLEX | Radiometer Medical ApS | 2016-09-01 |