Product code MQM— Clinical Chemistry
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
- Classification name
- Bilirubin (Total And Unbound) In The Neonate Test System
- Device class
- Class 1
- Regulation
- 21 CFR 862.1113
- Advisory panel
- Clinical Chemistry
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code MQM
FDA has cleared devices under product code MQM between 1992 and 2017, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2017
- 2014
- 2011
- 2008
- 2005
- 2004
- 2003
- 2001
- 2000
- 1999
- 1998
- 1997
- 1992
Top applicants under product code MQM
Recent clearances under product code MQM
- K170882 — ABL90 FLEX, ABL90 FLEX PLUS
- K132691 — ABL90 FLEX
- K133175 — DRAEGER JAUNDICE METER JM-105
- K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN
- K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
- K042522 — JAUNDICE METER, MODEL JM 103
- K040174 — BILIRUBIN ASSAY ON THE OMNI S ANALYZER
- K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
- K001687 — COLORMATE TLC BILITEST SYSTEM
- K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER
- K994438 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
- K983071 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
- K983134 — NBIL
- K972309 — JM-102 JAUNDICE METER
- K980646 — IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
- K964590 — COLORMATE III
- K922770 — UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311
Data sourced from openFDA. This site is unofficial and independent of the FDA.