Atlas FDA

MQM

17 FDA 510(k) clearances · Product code

193 daysmedian time to decision
459 days90th percentile
17clearances measured

FDA profile

Official device name
Bilirubin (Total And Unbound) In The Neonate Test System
Device class
Class I (low risk)
Regulation
21 CFR 862.1113
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 5 · 2008: 3 · 2010: 4 · 2024: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ABL90 FLEX, ABL90 FLEX PLUS (K170882)Radiometer Medical Aps2017-04-28
DRAEGER JAUNDICE METER JM-105 (K133175)Draeger Medical Systems, Inc.2014-11-13
ABL90 FLEX (K132691)Radiometer Medical Aps2014-11-13
RAPIDPOINT 405 NEONATAL BILIRUBIN (K110277)Siemens Healthcare Diagnostics2011-08-15
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (K073537)Siemens Medical Solutions Diagnostics2008-06-27
JAUNDICE METER, MODEL JM 103 (K042522)Draeger Medical Infant Care, Inc.2005-07-06
BILIRUBIN ASSAY ON THE OMNI S ANALYZER (K040174)Roche Diagnostics Corp.2004-05-14
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (K021622)Hill-Rom Air-Shields2003-04-01
COLORMATE TLC BILITEST SYSTEM (K001687)Chromatics Color Sciences Intl., Inc.2001-09-13
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (K010052)Respironics, Inc.2001-03-19
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K994438)Spectrx, Inc.2000-02-04
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K983071)Respironics, Inc.1999-03-04
NBIL (K983134)Abbott Laboratories1998-09-23
JM-102 JAUNDICE METER (K972309)Air-Shields, Inc.1998-09-22
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES (K980646)Instrumentation Laboratory CO1998-05-06
COLORMATE III (K964590)Chromatics Color Sciences Intl., Inc.1997-07-24
UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 (K922770)Leica, Inc.1992-08-18

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Every clearance here is in the API, with alerts when new ones post.