Jaundice Meter, Model JM 103
FDA 510(k) K042522 · Draeger Medical Infant Care, Inc.
510(k) numberK042522
Submission
- Device name
- Jaundice Meter, Model JM 103
- Applicant
- Draeger Medical Infant Care, Inc.
Hatboro, PA, US - Received
- September 16, 2004
- Decision date
- July 6, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQM – Bilirubin (Total And Unbound) In The Neonate Test System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1113
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | Radiometer Medical Aps | 04/28/2017SE |
| K133175 | Draeger Jaundice Meter JM-105MQM · Traditional | Draeger Medical Systems, Inc. | 11/13/2014SE |
| K132691 | ABL90 FlexMQM · Traditional | Radiometer Medical Aps | 11/13/2014SE |
| K110277 | Rapidpoint 405 Neonatal BilirubinMQM · Traditional | Siemens Healthcare Diagnostics | 08/15/2011SE |
| K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265MQM · Traditional | Siemens Medical Solutions Diagnostics | 06/27/2008SE |
| K040174 | Bilirubin Assay on the Omni S AnalyzerMQM · Traditional | Roche Diagnostics Corp. | 05/14/2004SE |
| K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103MQM · Traditional | Hill-Rom Air-Shields | 04/01/2003SE |
| K001687 | Colormate TLC Bilitest SystemMQM · Traditional | Chromatics Color Sciences Intl., Inc. | 09/13/2001SE |
| K010052 | Respironics Bilichek NON-INVASIVE-100-0800-20; Bilirubin AnalyzerMQM · Abbreviated | Respironics, Inc. | 03/19/2001SE |
| K994438 | Bilichek Non-Invasive Bilirubin AnalyzerMQM · Traditional | Spectrx, Inc. | 02/04/2000SE |
More from Spectrx, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K053399 | Versalet 7700 Care CenterFMZ · Traditional | 08/04/2006SE |
Questions and answers
When was Jaundice Meter, Model JM 103 cleared by the FDA?
Jaundice Meter, Model JM 103 (K042522) received a 510(k) decision of Substantially Equivalent on July 6, 2005, 293 days after the submission was received.
What is the product code of K042522?
The FDA product code is MQM – Bilirubin (Total And Unbound) In The Neonate Test System, a Class I (low risk) device regulated under 21 CFR 862.1113.