FDA Product Code
FDA Product Code MQM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1113
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170882 | ABL90 FLEX, ABL90 FLEX PLUS | Radiometer Medical Aps | 2017-04-28 | Traditional | PDF ↗ |
| K132691 | ABL90 FLEX | Radiometer Medical Aps | 2014-11-13 | Traditional | PDF ↗ |
| K133175 | DRAEGER JAUNDICE METER JM-105 | Draeger Medical Systems, Inc. | 2014-11-13 | Traditional | PDF ↗ |
| K110277 | RAPIDPOINT 405 NEONATAL BILIRUBIN | Siemens Healthcare Diagnostics | 2011-08-15 | Traditional | PDF ↗ |
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | Siemens Medical Solutions Diagnostics | 2008-06-27 | Traditional | PDF ↗ |
| K042522 | JAUNDICE METER, MODEL JM 103 | Draeger Medical Infant Care, Inc. | 2005-07-06 | Traditional | PDF ↗ |
| K040174 | BILIRUBIN ASSAY ON THE OMNI S ANALYZER | Roche Diagnostics Corp. | 2004-05-14 | Traditional | PDF ↗ |
| K021622 | HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 | Hill-Rom Air-Shields | 2003-04-01 | Traditional | PDF ↗ |
| K001687 | COLORMATE TLC BILITEST SYSTEM | Chromatics Color Sciences Intl., Inc. | 2001-09-13 | Traditional | PDF ↗ |
| K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | Respironics, Inc. | 2001-03-19 | Abbreviated | PDF ↗ |
| K994438 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Spectrx, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K983071 | BILICHEK NON-INVASIVE BILIRUBIN ANALYZER | Respironics, Inc. | 1999-03-04 | Traditional | PDF ↗ |
| K983134 | NBIL | Abbott Laboratories | 1998-09-23 | Traditional | PDF ↗ |
| K972309 | JM-102 JAUNDICE METER | Air-Shields, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K980646 | IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES | Instrumentation Laboratory CO | 1998-05-06 | Traditional | PDF ↗ |
| K964590 | COLORMATE III | Chromatics Color Sciences Intl., Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K922770 | UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 | Leica, Inc. | 1992-08-18 | Traditional | PDF ↗ |
Product code MQM · Class I · Clinical Chemistry. Data: openFDA.